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3289 Study Matches

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NRG-BR007, A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)

Dean Shumway
All
50 years to 70 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305950-P01-RST
21-009845
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Inclusion Criteria:

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
  • The patient must have an ECOG performance status of 0 or 1.
  • The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection).
  • The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
  • Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection).
  • The following staging criteria must be met postoperatively according to AJCC 8th edition criteria:
    • By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm);
    • By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible);
    • Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen;
      • ** For patients with a T1a tumor (less than or equal to 0.5 cm in size) who do not already have an Oncotype DX Recurrence Score at study entry, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory.
    • The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive;
    • The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines.
  • Patients may be premenopausal or postmenopausal at the time of study entry. For study purposes, postmenopausal is defined as: age 56 or older with no spontaneous menses for at least 12 months prior to study entry; or a documented hysterectomy; or age 55 or younger with no spontaneous menses for at least 12 months prior to study entry (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or documented bilateral oophorectomy.
  • The interval between the last surgery for breast cancer (including re-excision of margins) and study entry must be no more than 70 days.
  • The patient must have recovered from surgery with the incision completely healed and no signs of infection.
  • Bilateral mammogram or MRI within 6 months prior to study entry. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion.


Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease. -pT2
    •pT4 tumors including inflammatory breast cancer.
  • Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease.
  • Patient had a mastectomy.
  • Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible).
  • Paget's disease of the nipple.
  • Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible).
  • Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible).
  • Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible).
  • Treatment plan that includes regional nodal irradiation.
  • Any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy administered for the currently diagnosed breast cancer prior to study entry. (Short course endocrine therapy of less than 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry.
  • Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. (Short course endocrine therapy of < 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18).
  • Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible.
  • Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible.
  • Prior breast or thoracic RT for any condition.
  • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at the time of study entry or intention to become pregnant during treatment.
    • Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to study entry.
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results.
  • Use of any investigational product within 30 days prior to study entry.

Eligibility last updated 9/20/21. Questions regarding updates should be directed to the study team contact.

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Bladder Bank (Bladder Bank)

Bladder Bank

John Kisiel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305962-H01-RST
21-009854
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Inclusion Criteria:
  

  • Age ≥ 18 years.
  • Patient has undergone office-based evaluation for hematuria (CT, ultrasound, cystoscopy).


Exclusion Criteria:
  

  • Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible).
  • Patient has recurrent bladder cancer.
  • Patient has ever been previously diagnosed with UTUC (Upper Tract Urothelial Carcinoma) prior to bladder resection.
  • Patient has prior diagnosis of bladder cancer for which intravesical immunotherapy (BCG) or chemotherapy (Mitomycin, Valrubicin) was provided.
  • Patient has received chemotherapy class drugs for the treatment of cancer in the 5 years prior to current collection.
  • Patient has had any prior radiation therapy to the target lesion prior to current collection.
  • Patient has had a biopsy to the target organ and/or lesion within 3 days before collection.
  • Patient has undergone cystectomy.
  • Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection.
  • Patient has had a urinary tract infection within 14 days prior to urine collection.
  • Patient has chronic indwelling urinary catheter 
  • Patient has prior diagnosis of bladder cancer for which prior resection of tumor was performed.

Eligibility last updated 6/29/22. Questions regarding updates should be directed to the study team contact.

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Immune Checkpoint Inhibition and Humoral Immune Response in Systemic Autoimmunity (ICIRA)

ICI and Response in Autoimmunity

Hu Zeng
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305966-H01-RST
21-009862
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Inclusion Criteria:

  • Adults, age ≥ 18 years.
  • Any concomitant malignancy being treated with any PD-1 inhibitor (pembrolizumab, nivolumab or cemiplimab) as monotherapy and the presence of inflammatory arthritis defined by:
    • provider documented inflammatory arthritis (meet 2010 EULAR/ACR classification criteria of RA) in one or more large or small joints; and at least one or more of the following:
    • elevated inflammatory markers;
    • supportive imaging and/or supportive synovial fluid analysis.


Exclusion Criteria:

  • Active infection.
  • Prior history of the rheumatic disease.
  • Any B cell depletion therapy.
  • PActive use of high (≥ 30 mg daily) of prednisone or steroid equivalent.
  • Clinical features suggestive of non-RA autoimmune rheumatic disease (e.g., lupus, Sjogren’s, psoriatic arthritis, etc.) or axial spondyloarthropathy.

Eligibility last updated 9/21/21. Questions regarding updates should be directed to the study team contact.

 

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A Real-world Comparative Effectiveness Trial of Treatment Strategies in Patients with Rheumatoid Arthritis: The RA-PRO (Patient Reported Outcomes) Pragmatic Trial (RA-PROPR) (RA-PROPR)

RA-PRO PRAGMATIC TRIAL

Lynne Peterson
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305970-P01-RST
21-009875
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Inclusion Criteria:

  • Prior TNFi biologic treatment – Patient has active, moderate-high disease activity RA (CDAI ≥ 10 and HAQ ≥ 0.5) despite the use/experience for ≥ 3 months of a TNFi-biologic OR discontinued the medication(s) due to intolerability or toxicity irrespective of treatment duration prior to the first dose of study drug; AND
  • Glucocorticoid and NSAID treatment
    •If receiving glucocorticoids (≤ 10 mg/day of prednisone of equivalent) or NSAIDs, on stable doses for ≥ 2 weeks prior to randomization; AND
  • Insurance
    •Insurance plan or patient assistance program allows access to at least 1 drug in each of the two treatment strategies for 1 year trial duration. Participants will be allowed to continue their conventional synthetic DMARD (csDMARD) therapy if they had been using it for ≥ 3 months and on a stable dose for ≥ 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed: methotrexate (MTX), sulfasalazine, hydroxychloroquine, and leflunomide (TNFi-biologic and tsDMARD) through insurance plan or a patient assistance program/plan.


Exclusion Criteria:

  • Prior treatment with more than three biologics, defined as TNFi-biologic or non-TNFi biologic.
  • Prior treatment with targeted synthetic DMARD.
  • Concomitant use of cyclosporine, or azathioprine within 2-months before randomization.
  • History of sensitivity to all 4 non-TNF-biologic or a targeted synthetic DMARD.
  • Glucocorticoid injection (intravenous, intramuscular, or intraarticular) within 1 month of study entry.
  • Live vaccine within 90 days of study entry.
  • Acute infection treated with parenteral antibiotics or hospitalization within 1 month or with oral antibiotics within 2 weeks of study entry; or chronic infections requiring long-term antibiotic suppressive therapy.
  • History of HIV or opportunistic infections.
  • New York Heart Association Class III or IV heart failure.
  • Latent TB not treated with anti-mycobacterial medication.
  • Untreated Hepatitis B or C infection.
  • History of deep venous thrombosis or pulmonary embolism.
  • Pregnant or nursing women.
  • History of herpes zoster or shingles.

Eligibility last updated 6/1/22. Questions regarding updates should be directed to the study team contact.

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A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial) (TRIUMPH)

Tadalafil vs. Placebo to Improve Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Alexander Egbe
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305977-H01-RST
21-009890
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Inclusion Criteria:


- Patients ≥ 18 years old.

- Have previously undergone a Fontan Palliation.

- Able to exercise using a supine bike.

- Able to undergo an MRI.

- Ability and willingness to provide written consent.

- Undergoing a clinically indicated Cardiac Catheterization


Exclusion Criteria:


- Patients < 18 years old.

- Current intravenous inotropic drugs.

- Current use of alpha-blockers, pulmonary vasodilators, or nitrates.

- Unable to exercise.

- Pregnancy or lactating.

- Unable or unwilling to consent.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 7/26/22. Questions regarding updates should be directed to the study team contact.

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ORIC-533-01, An Open-label Phase 1b Study of ORIC-533 in Patients With Relapsed or Refractory Multiple Myeloma (ORIC-533-01)

Study of ORIC-533 in Relapsed or Refractory Multiple Myeloma

Wilson Gonsalves
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305995-P01-RST
21-010004
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Inclusion Criteria:
-Diagnosis of multiple myeloma (MM) with relapsed or refractory disease according to IMWG Criteria -Refractory to or not eligible for MM treatment regimens known to provide clinical benefit, including but not limited to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, with documented disease progression -Measurable disease at screening, including at least 1 of the criteria below: -Serum M-protein >0.5 g/dL (Patients with IgA myeloma in whom serum M protein is unreliable due to comigration of normal serum proteins may be considered eligible if total IgA >400 mg/dL) -Urine M-protein >200 mg/24 hours -Serum free light chains (FLC) assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum FLC ratio (<0.26 or >1.65) -Measurable bone or extramedullary plasmacytoma -ECOG performance status ≤2 -Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as: -Estimated glomerular filtration rate ≥60 mL/min/1.73 m2. -Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels both ≤3 times of upper limit of normal, unless there is suspected disease in the liver, in which case, no limit is set provided serum bilirubin is within eligibility criterion -Total bilirubin <1.5 × upper limit of normal (ULN), except in study participants with Gilbert's syndrome -Platelet count >50,000/μL -Absolute neutrophil count (ANC) >1000/μL -Left ventricular ejection fraction (LVEF) >45% as assessed by echocardiogram (ECHO) or multiple gated acquisition (MUGA) -Baseline oxygen saturation >92% on room air
Exclusion Criteria:
-Diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low risk prostate cancer after curative therapy -Previous or concurrent plasma cell leukemia, AL amyloidosis, or POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome -Known central nervous system (CNS) involvement -Evidence of hyperviscosity syndrome -Receiving any investigational treatment with a novel investigational agent (ie, no approved indication) within 28 days prior to the first dose of study drug -Not recovered or stabilized from all toxicities from prior anticancer therapies and/or radiotherapy to Grade <2 with the exception of peripheral neuropathy -Major surgery or radiation therapy within 14 days prior to first dose of study drug or incomplete recovery from adverse effects resulting from such procedure -Those who require limited course of radiation for management of bone pain for ≤14 days from initiation of therapy are not excluded -Infection requiring systemic antibiotic therapy or other serious infection within 14 days of starting therapy -Those who are on prophylactic antibiotics only, or on antibiotics and have confirmation of resolution of active infection, are eligible -Daily requirement for corticosteroids (equivalent to >10 mg/day prednisone). Inhalation corticosteroids are exempt from this criterion -Exception: Corticosteroid dose equivalent >10 mg/day prednisone is acceptable if physiological levels require, so long as the dose is stable for at least 7 days prior to initiation of therapy -Lower amounts of corticosteroids that are not part of a daily requirement within 14 days prior to initiating therapy are also acceptable -Known seropositive for active viral infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV). Those who are seropositive because of hepatitis B vaccine are eligible. Patients who are positive for HBV core antibody or HBV surface antigen must have a negative polymerase chain reaction (PCR) result prior to enrollment. Those who are PCR positive will be excluded. -History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months of first dose of study drug -QTcF >470 msec -Other concurrent serious uncontrolled medical, psychological, or addictive conditions that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study
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Detection of Colorectal Cancer or Advanced Neoplasia by Stool DNA in Lynch Syndrome: CORAL Study (CORAL)

Collecting Blood and Stool Samples to Detect Colorectal Cancer or Advanced Neoplasia in Lynch Syndrome Patients, CORAL Study

John Kisiel
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305999-P01-RST
21-010010
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Inclusion Criteria:


- Patients at least 18 years of age

- Individuals diagnosed with Lynch syndrome (mutation in MLH1, MSH2, MSH6, PMS2, EPCAM)
or suspected Lynch syndrome or individuals diagnosed with early onset colorectal
cancer (CRC) (< 50 years old [yo])

- Colonoscopy/flexible sigmoidoscopy (flex sig) scheduled +/- 90 days from sample
collection

- Patient has agreed to participate and has signed the study consent form


Exclusion Criteria:


- Patient has known cancer (stage I-IV) 5 years prior to current sample collection (not
including basal cell or squamous cell skin cancers; if patient has not been seen or if
information is not available, the patient is eligible)

- Patient has received chemotherapy class drugs for the treatment of cancer in the 5
years prior to current sample collection

- Patient has had any abdominal radiation therapy prior to current sample collection

- Patient had therapy to the target lesion with intent to completely remove or debulk
the lesion prior to sample collection (examples include snare polypectomy, endoscopic
mucosal resection [EMR], endoscopic submucosal dissection [ESD], surgical resection,
trans anal excision)

- Patient has prior diagnosis of non-lynch hereditary colon cancer syndrome (familial
adenomatous polyposis [FAP], MUTYH-associated polyposis [MAP], Peutz-Jeghers syndrome
[PJS], juvenile polyposis syndrome [JPS], PTEN, POL)

- ADDITIONAL STOOL EXCLUSIONS:

- Bowel prep < 7 days prior to stool collection

- Oral or rectal contrast given within 7 days prior to stool collection

- Removal of more than 50% of colon or presence of ileostomy

- Enteral feeds or total parenteral nutrition (TPN)

- Diagnosis of inflammatory bowel disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 1/13/23. Questions regarding updates should be directed to the study team contact.

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ALKS 4230-006, A Phase 2, Open-label, Multicenter, Cohort Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy Administered Subcutaneously in Patients With Advanced Cutaneous Melanoma or Intravenously in Patients With Advanced Mucosal Melanoma Who Have Previously Received Anti-PD-[L]-1 Therapy - ARTISTRY-6 (ARTISTRY-6)

Nemvaleukin Alfa (ALKS 4230) Monotherapy in Patients With Advanced Cutaneous Melanoma or Advanced Mucosal Melanoma

Matthew Block
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306026-P01-RST
21-010085
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Inclusion Criteria:

  • Patient is ≥ 18 years of age.
  • Patient or patient’s legal representative is willing and able to provide written informed consent.
  • Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
  • The patient must have advanced cutaneous melanoma or acral melanoma; no more than 5 patients with acral melanoma may enroll in this cohort (Cohort 1). Or, the patient must have unresectable and/or metastatic mucosal melanoma (Cohort 2).
  • Patient must have received previous treatment as follows:
    • patient has received anti-PD-[L]1 therapy ± anti-CTLA-4 therapy, and ≤ 1 other prior regimen of systemic anti-neoplastic therapy;
    • patient should have experienced objective response (PR or CR) or SD as BOR to anti-PD-[L]1 therapy;
    • patients with BRAF mutations may or may not have received prior targeted therapy.
  • A patient who has received prior treatment with talimogene laherparepvec (TVEC) is allowed to enroll provided that last exposure to TVEC was ≥ 28 days prior to first exposure to nemvaleukin and that all injection-site reactions to TVEC have resolved. TVEC shall not be considered a prior regimen of systemic anti-neoplastic therapy, nor shall it be considered a systemic immunomodulatory agent.
  • Patient has at least one measurable lesion that qualifies as a target lesion based on RECIST 1.1. Tumor lesions situated in a previously irradiated area, or in an area subjected to other locoregional therapy, are not considered measurable unless there has been demonstrated progression in the lesion.
  • Patient is willing to undergo a pretreatment tumor biopsy or provide qualifying archival tumor tissue. To qualify, archival tissue must have been sampled after last exposure to any systemic anti-neoplastic agent (including TVEC). Patients unable to undergo a biopsy may be enrolled if risk/benefit ratio of biopsy is considered unfavorable and/or when a biopsy would likely lead to significant delays in care. This decision must be accompanied by supporting documentation from the Investigator and performed in consultation with Medical Monitor. All pretreatment tissue must have been collected no more than 120 days prior to screening.
  • Patient has recovered from the effects of any previous chemotherapy, immunotherapy, other prior systemic anticancer therapy, radiotherapy, and/or surgery (i.e., residual toxicity no worse than Grade 1 [Grade 2 treatment-associated peripheral neuropathy and/or any grade of alopecia are acceptable assuming all other inclusion criteria are met]).
  • Patient who has received prior systemic anti-neoplastic agent(s) must wait at least 5 half-lives or 4 weeks (whichever is shorter) following prior therapy before enrollment into the study, or 4 weeks if the half-life of a given investigational agent is not known.
  • Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 within 5 days before the first dose of study drug and an estimated life expectancy of at least 3 months.
  • Patient has adequate hematologic reserve as evidenced by:
    • Absolute neutrophil count (ANC) of ≥ 1000/µL;
    • Absolute lymphocyte count of ≥ 500/µL;
    • Platelet count of ≥ 75,000/µL; and
    • Hemoglobin of ≥ 9 g/dL (patients may be transfused to this level if necessary, but transfusion must occur > 1 week prior to the first dose of study drug).
  • Patient has adequate hepatic function as evidenced by aspartate transaminase and alanine transaminase values ≤ 3 × the upper limit of normal (ULN) and serum total bilirubin values of ≤ 1.5 × ULN (≤ 2 × ULN for patients with known Gilbert’s syndrome) for the reference laboratory measured within 7 days prior to the first dose of study drug. For patients with documented baseline liver metastasis, the following limits will apply: 5 × ULN for transaminase and 2 × ULN for bilirubin.
  • Patient has adequate renal function as evidenced by a serum creatinine ≤ 1.5 × the ULN for the reference laboratory or a calculated creatinine clearance of ≥ 45 mL/min by the Cockcroft-Gault Equation measured within 7 days prior to the first dose of study drug.
  • Patient has international normalized ratio (INR) AND/OR prothrombin time (PT) AND activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN unless the patient is receiving anticoagulant therapy, in which case INR and/or PT and aPTT must be within the desired therapeutic range of intended use for such anticoagulants.
  • Patient agrees to abide by the contraceptive requirements detailed in the protocol.
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test (serum or urine) within 3 days before the first dose of study drug (see the protocol for the definition of WOCBP).


Exclusion Criteria:

  • Patient has uveal melanoma.
  • Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
  • Patient has received radiotherapy within the last 4 weeks before start of study treatment, with the exception of limited field palliative radiotherapy to an area not inclusive of or adjacent to the target lesion(s), that has been completed at least 2 weeks before starting study treatment with no ongoing acute sequelae (eg, radiation burns).
  • Patient requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent) or patient has taken systemic corticosteroids (> 10 mg of prednisone daily, or equivalent) within 14 days prior to the first dose of study drug; however, replacement doses, topical, ophthalmologic, and inhalational steroids are permitted.
  • Patient has taken non-steroid systemic immunomodulatory agents (e.g., Enbrel®, Humira®, etc) within 28 days prior to the first dose of study drug or anticipates use of these therapies during the study period.
  • Patient has undergone prior solid organ and/or non-autologous hematopoietic stem cell or bone marrow transplant.
  • Patient has received a live or live-attenuated vaccine(s) within 30 days prior to the first dose of study treatment.
    • Note: COVID-19 vaccine is allowed.
  • Patient has received more than 3 doses of therapeutic systemic broad-spectrum antibiotics within 14 days prior to the first dose of study drug. Antibiotics given for peri-procedural prophylaxis or given presumptively for a limited time (eg, until infection was ruled out), as well as topical or intra-ocular antibiotics, shall not be exclusionary.
  • Patient has had any active infection and/or a fever ≥ 38.5°C (≥ 101°F) within 3 days prior to the first dose of study drug.
  • Patient has active autoimmune disease(s) requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that has required chronic or frequent systemic steroids. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
  • Patient has underlying chronic lung disease, chronic obstructive pulmonary disease, metastatic lung disease, pleural effusions or other lung disorders (eg, pulmonary embolism) with a baseline room air oxygen saturation of < 92% at screening, and/or dyspnea (≥ Grade 3), which requires oxygen therapy.
  • Patient has any other concurrent uncontrolled illness, including mental illness or substance use, which may interfere with the ability of the patient to cooperate and participate in the study. Other examples of such conditions would include unstable, poorly controlled, or severe hypertension; clinically significant pericardial effusion; New York Heart Association Class III or Class IV congestive heart failure; high risk cardiovascular disease, defined as unstable angina, myocardial infarction, or cerebrovascular accident within 6 months of first dose; uncontrolled diabetes mellitus that has required 2 or more hospitalizations in the last year and/or emergent management within the last 6 months; severe peripheral vascular disease; or recent serious trauma.
  • Patient has had an active second malignancy within the previous 2 years. This criterion does not apply to patients with adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, prostate cancer of highest Gleason score ≤ 6 with undetectable prostate-specific antigen over the previous 12 months, urothelial carcinoma in situ, or ductal carcinoma in situ of the breast that has undergone full surgical resection.
  • Patient is currently pregnant, breastfeeding, or is planning to become pregnant or to begin breastfeeding during the study period or within 30 days after last study drug administration.
  • Patient has active or symptomatic central nervous system metastases unless all the following have been met: such metastases have been treated by surgery and/or radiation therapy, and/or gamma knife and have remained radiographically stable (or shrinking) on 2 consecutive imaging examinations performed at least 6 weeks apart; AND steroids have been tapered to a dose of 10 mg of prednisone (or equivalent) or less for at least 2 weeks prior to first dose of study agent(s); AND the patient is neurologically stable. Patients with history of brain metastases or a suspicion of brain metastases must have a brain magnetic resonance imaging (MRI) at baseline (Screening Visit).
  • Patient has known or suspected hypersensitivity to any components of nemvaleukin.
  • Patient has active uncontrolled coagulopathy.
  • Patient has QT interval corrected by the Fridericia Correction Formula values of > 470 msec (in females) or > 450 msec (in males); patient who is known to have congenital prolonged QT syndromes; or patient who is on medications known to cause prolonged QT interval on ECG.
  • Patient is known to be positive for human immunodeficiency virus. Patients with known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) are excluded; however, a patient with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) may be enrolled provided that HBV DNA is negative. Patients with known active hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] are detected) are excluded, however, a patient with cured hepatitis C (negative HCV RNA status) may be enrolled.
  • Patient has active or latent tuberculosis. Patients with cured tuberculosis may be enrolled.
  • Patient has developed Grade ≥ 3 immune-related adverse events (irAEs) while on prior immunotherapy (e.g., pneumonitis, nephritis, and neuropathy). Patients who have immunerelated endocrinopathies and are stable on hormone replacement therapy are not excluded. Patients who experienced colitis as a toxicity of prior immunotherapy must have undergone colonoscopy since last symptoms of colitis that confirms the absence of ongoing inflammation. Vitiligo is not exclusionary.

Eligibility last updated 9/24/21. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Colon melanoma, Melanoma, Metastatic melanoma, Rectal melanoma, Skin cancer
Acral lentiginous malignant melanoma of skin, Cancer treatment, Integumentary system, Malignant melanoma of mucous membrane, Malignant melanoma of skin, Medical Oncology, Metastatic malignant melanoma
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Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty: A single institution, single-blinded, randomized clinical trial

Periarticular Bupivacaine + Meloxicam ER Solution Versus Standard Practice During Total Knee Arthroplasty

Matthew Abdel
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306039-H01-RST
21-010044
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Inclusion Criteria:

  • ASA classification I to III, older than or equal to 18 years old.
  • All genders.
  • Presenting for primary total knee replacement for degenerative joint disease.
  • Patient capable of providing their own informed consent.


Exclusion Criteria:

  • Vulnerable study populations including prisoners.
  • Patients with a contralateral total knee arthroplasty < 2 years prior to the index procedure.
  • Compromised health barring them from proceeding with surgery including acute or chronic kidney injury identified pre-operative.
  • Patients unable to provide their own informed consent.
  • Pregnancy.
  • Patients with documented chronic pain syndromes.
  • Patients with a history of prolonged daily opioids (more than 1 month) with an oral morphine equivalent of greater than 5mg/day.
  • BMI > 45 kg/m^2.
  • Allergies to any component of the study medications, including specific history of type 1 hypersensitivities to any NSAID.
  • Patients with impaired cognitive function.
  • Major systemic illnesses such as severe renal (estimated glomerular filtration rate less than 50ml/min), coronary artery disease requiring a bypass graft (CABG), other cardiac problems including congestive heart failure (CHF New York Heart Association class III to IV), or severe hepatic disorders defined as current or past diagnosis of acute/subacute liver necrosis, acute hepatic failure, chronic liver disease, liver abscess, hepatic coma, hepatorenal syndrome and other disorders of the liver.

Eligibility last updated 10/12/21. Questions regarding updates should be directed to the study team contact.

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2020-0641, Pembrolizumab in Combination with Dabrafenib and Trametinib as a Neoadjuvant Strategy Prior to Surgery in BRAF-mutated Anaplastic Thyroid Cancer

Pembrolizumab, Dabrafenib, and Trametinib Before Surgery for the Treatment of BRAF-Mutated Anaplastic Thyroid Cancer

Mabel Ryder
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306042-P01-RST
21-010193
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Inclusion Criteria:

  • Pathologic findings supporting the clinical impression of anaplastic thyroid  carcinoma. Diagnosis may include consistent with or suggestive of terminology  associated with: anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous  carcinoma; carcinoma with spindled, giant cell, or epithelial features; poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present.
  • Must have a BRAFV600E mutation-positive tumor, as determined by BRAF V600E  immunohistochemistry on tumor tissue, genetic/molecular testing of tumor, or cell free  (cf)NDA liquid biopsy.
  • Have measurable disease based on RECIST 1.1.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN). Total bilirubin ≤ 3 x ULN for  patients with Gilbert's syndrome.
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase  [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])  ≤ 2.5 x ULN, (5 x ULN for patients with concurrent liver metastases).
  • Serum creatinine ≤ within 1.5 x ULN.
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L.
  • Platelets ≥ 100 x 10^9/L.
  • Hemoglobin ≥ 9.0 g/dL or 5.6 mmol/L.
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless  participant is receiving anticoagulant therapy as long as PT or activated partial  thromboplastin time (aPTT) is within therapeutic range of intended use of  anticoagulant.
  • Subjects must be willing to undergo tumor biopsy prior to and after the run-in with dabrafenib/trametinib (DT), unless in the opinion of the treating physician, a biopsy is not feasible or safe. Subjects must be willing to ultimately undergo surgery if  their tumor becomes surgically resectable. Research subjects retain the right to  refuse any research interventions.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.  Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • A male participant must agree to use a contraception of this protocol during the  treatment period and for at least 8 months after the last dose of study treatment and  refrain from donating sperm during this period.
  • A female participant is eligible to participate if she is not pregnant, not  breastfeeding, and at least one of the following conditions applies:  
    • Not a woman of childbearing potential (WOCBP); OR
    • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 6 months after the last dose of study treatment.


Exclusion Criteria:
 

  • Significant cardiovascular impairment: history of congestive heart failure greater  than New York Heart Association (NYHA) class II.
  • Untreated brain metastases.
  • Prior chemotherapy within < 1 week prior to study day 1 or patients who have not  recovered (i.e., ≤ grade 2) from adverse events due to a previously administered  agent, except for patients who have been on dabrafenib/trametinib (DT) according to  the standard run-in outlined in the trial schema.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years  (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid  replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • History of human immunodeficiency virus (HIV) or active hepatitis B (chronic or acute)  or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive  anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible. However,  patients with past or resolved hepatitis B virus (HBV) should be monitored for  reactivation by a specialist. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic  acid (RNA).
    • Note: no testing for HIV, hepatitis B and hepatitis C is required unless  mandated by local heath authority.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
  • Has received a live or live-attenuated vaccine within 30 days prior to the first dose  of study drug. Administration of killed vaccines is allowed.
  • Has severe hypersensitivity (≥ grade 3) to pembrolizumab and/or any of its excipients.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required  steroids or has current pneumonitis/interstitial lung disease.
  • Has known psychiatric or substance abuse disorders that would interfere with  cooperation with the requirements of the trial.
  • Females who are breastfeeding or pregnant at screening or baseline (as documented by a positive beta-human chorionic gonadotropin [beta-hCG] (or human chorionic gonadotropin  [hCG]) test with a minimum sensitivity of 25 IU/L or equivalent units of beta-hCG [or hCG]). A women of childbirth potential (WOCBP) who has a positive urine pregnancy test within 72 hours prior to the first infusion will be excluded. If the urine test is  positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • More than 30 days of DT therapy prior to enrollment.
  • A known history of retinal vein occlusion (RVO), central serous retinopathy (CSR), uncontrolled glaucoma or ocular hypertension.

Eligibility last updated 9/27/21. Questions regarding updates should be directed to the study team contact.

 

Drug, Procedure/Surgery, Radiation, Other
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TBCRC056: A Phase II Study of Niraparib With Dostarlimab Therapy as Neoadjuvant Treatment for Patients With BRCA-mutated Breast Cancer

Niraparib + TSR042 In BRCA Mutated Breast Cancer

Roberto Leon Ferre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306050-P01-RST
21-010544
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Inclusion Criteria:


- Participants must meet the following criteria on screening examination to be eligible
to participate in the study. Laboratory assessments for eligibility must be completed
within 14 days prior to the date of registration. Diagnostic imaging, such as MRIs and
CT scans, must be performed within 28 days of the planned treatment start.

- Participants must have histologically or cytologically confirmed invasive breast
cancer Stage I to III with primary tumor size at least 1.5 cm defined by physical exam
or imaging (whichever is larger). In the case of a multifocal, multicentric, or
bilateral disease, the largest lesion must be ≥ 1.5 cm and designated as the "index"
lesion for tumor evaluations. Patients with inflammatory breast carcinoma are not
eligible.

- Participants must have documentation of estrogen receptor (ER) and progesterone
receptor (PR) testing by IHC according to local institutional guidelines in a
CLIA-approved setting. Central confirmation of ER/PR status is not required. All
tumors must be HER2 negative.

- Arms A and B: Target lesion must be ER and PR negative (<10% staining) by local
review.

- Arm C: Target lesion must be ER and/or PR positive (>10% staining) by local
review.

- Participants must have documented HER2-negative invasive tumor according to local
institutional guidelines in a CLIA-approved setting. Central confirmation of HER2
status is not required. HER2 negative is defined as:

- 0 or 1+ by IHC, OR

- Lack of gene amplification with HER2/CEP17 ratio < 2 by ISH, OR

- Copy number < 6 by ISH

- Participants must have documented germline mutation in BRCA1, BRCA2 or PALB2 that is
deleterious or suspected to be deleterious (known or predicted to be detrimental/lead
to loss of function). Mutation must be identified through a CLIA-approved laboratory.
Final determination of eligibility for any discordant results in pathogenicity will be
made by the sponsor-investigator. A formal eligibility exception will not be required
in these cases as long as approval by overall study PI is granted and documented.

- Participants with multifocal, multicentric or bilateral disease are eligible if at
least one lesion meets criteria for the study. In this circumstance, the investigator
must determine which will represent the target lesion to be assessed for response.
This should remain consistent throughout the study. The target lesion should be
selected on the basis of its size (lesion with the longest diameter) and suitability
for accurate repetitive measurements.

- Participants with an eligible target lesion, and another small HER2+ tumor (for
example, < 6 mm), may be eligible for enrollment following discussion and agreement
with the overall principal investigator. A formal eligibility exception will not be
required in these cases as long as approval by the sponsor-investigator is granted and
documented.

- Female or male ≥ 18 years of age

- Breast imaging should include imaging of the ipsilateral axilla. For subjects with a
clinically positive axilla by physical examination or imaging, axillary tissue
acquisition is not required. For patients with a clinically negative axilla by
examination and imaging, tissue acquisition is not required. For equivocal imaging
findings, tissue acquisition (a needle aspiration, core biopsy) is required. Sentinel
Lymph Node (SLN) biopsy before neoadjuvant therapy is not allowed.

- ECOG performance status of 0 or 1

- Adequate organ and bone marrow function as defined below:

- Absolute neutrophil count (ANC) ≥ 1500/mm3

- Platelet count ≥ 100,000/mm3

- Hemoglobin ≥ 9 g/dl

- Total serum bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), (≤2.0 in
patients with documented Gilbert's Syndrome)

- AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional ULN

- Serum or plasma creatinine ≤ 1.5 × institutional ULN, OR calculated creatinine
clearance > 50 mL/min using the Cockcroft-Gault equation

- International normalized ratio (INR) OR prothrombin time (PT) ≤1.5× ULN.
Participants who are receiving anticoagulant therapy are eligible as long as PT
or partial thromboplastin (PTT) is within therapeutic range of intended use of
anticoagulants. Activated partial thromboplastin time (aPTT) must be ≤1.5× ULN
unless patient is receiving anticoagulant therapy as long as PT or PTT is within
therapeutic range of intended use of anticoagulants

- Premenopausal women must have a negative urine or serum pregnancy test within 7 days
of treatment start. Women are considered non-childbearing (by other than medical
reasons) if they:

- are ≥45 years of age and without menses for >1 year

- have been amenorrhoeic for <2 years without history of a hysterectomy and
oophorectomy with a follicle stimulating hormone value in the postmenopausal
range upon screening evaluation

- are post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation.
Documented hysterectomy or oophorectomy must be confirmed with medical records of
the actual procedure or confirmed by an ultrasound. Tubal ligation must be
confirmed with medical records of the actual procedure, otherwise the patient
must be willing to use an adequate barrier method throughout the study, starting
with the screening visit through 180 days after the last dose of study treatment.
See list of acceptable birth control methods. Information must be captured
appropriately within the site's source documents. Note: Abstinence is acceptable
if this is the established and preferred contraception for the patient.

- Male and female participants of childbearing potential must agree to adhere to
adequate contraception as defined in the protocol for the duration of study
participation and for 150 days after the last dose of study treatment.

- Female participants must agree to not breastfeed during the study or for 150 days
after the last dose of study treatment.

- Participants must agree to not donate blood during the study or for 90 days after the
last dose of study treatment.

- Ability to understand and willingness to sign an informed consent document.

- Ability to swallow and retain oral medication.

- Patients undergoing breast conserving therapy (ie lumpectomy) should not have any
contraindications to radiation therapy.

- Participants must be willing to undergo the mandatory research biopsy at baseline and
after 3 weeks on study treatment. Participants who undergo an attempted research
biopsy procedure for the purpose of this protocol and in whom inadequate tissue is
obtained are not required to undergo a repeat biopsy in order to continue on the
protocol.


Exclusion Criteria:


- Stage IV breast cancer.

- Concurrent therapy with any other investigational product

- Prior treatment for the current breast cancer, including prior chemotherapy, immune
therapy, hormonal therapy, radiation, or investigational therapy for this diagnosis.

- Excisional biopsy of the primary tumor and/or excision of axillary lymph nodes,
including SLNB, prior to study treatment.

- Participants with a history of malignancy are ineligible except in the following
circumstances:

- Individuals with a history of invasive breast cancer are not eligible unless they
have been disease-free for a minimum of three years.

- Individuals with a malignancy history other than invasive breast cancer are
eligible if they have no active malignancy and are deemed by the investigator to
be at low risk for recurrence of that malignancy.

- Individuals with the following cancer history are eligible: adequately treated
nonmelanoma skin cancers, curatively treated in situ cancer of the cervix, ductal
carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma.

- Other exceptions may exist following agreement with the sponsor-investigator

- Patients with a diagnosis of immunodeficiency, or currently receiving systemic steroid
therapy or any other form of immunosuppressive within 7 days prior to the first dose
of study treatment. Use of local corticosteroid injections (e.g. intraarticular
injections), inhaled, intranasal, ophthalmic, and topical corticosteroids, and
subjects requiring corticosteroid pre-medication for hypersensitivity reactions (e.g.

CT scan pre-medication) are allowed.

- Patients with autoimmune disease that has required systemic treatment within the past
2 years (i.e. with use of disease-modifying agents, corticosteroids, or
immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic
corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is
not considered a form of systemic treatment.

- Patients with a history of interstitial lung disease or pneumonitis.

- Patients who have received a live vaccine within 2 weeks prior to the start of study
treatment.

- Patients who have undergone any major surgery within 3 weeks prior to study entry:

patients must have recovered to baseline from any effects of any major surgery.

- Patients with concurrent HIV infection are eligible provided they meet the following
criteria:

- CD4+ T-cell (CD4+) counts ≥ 350 cells/uL

- No history of AIDS-defining opportunistic infection within 12 months prior to
enrollment

- Any medication used in an antiretroviral therapy (ART) regimen must have no known
interaction with the study agents

- Patients with active or chronic Hepatitis B or C are eligible provided they meet the
liver function laboratory criteria described in 3.1.10 and cannot be on any medication
with a known interaction with the study agents

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure
disorder, unstable spinal cord compression, superior vena cava syndrome or psychiatric
illness/social situations that would limit compliance with study requirements.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to niraparib, dostarlimab, or their excipients.

- Transfusion (platelets or red blood cells) ≤ 4 weeks prior to initiating protocol
therapy.

- Known history of myelodysplastic syndrome (MDS) or or acute myeloid leukemia (AML).

Eligibility last updated 8/9/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1b/2 Study of the PARP Inhibitor Niraparib in Combination With Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer

Ciara O'Sullivan
Female
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-306053-P01-RST
21-012614
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Inclusion Criteria:

  • Women age ≥ 18 years.
  • Eastern Cooperative Oncology Group performance status 0-2 (Karnofsky >60%).
  • Patients with metastatic breast cancer.
  • HER2 (human epidermal growth factor receptor 2)-positive breast cancer prospectively determined on the primary tumor by a local pathology laboratory and defined as:
    • Immunohistochemistry (IHC) score of 3+ and/or positive by ISH (defined by In Situ Hybridization ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Both IHC and ISH assays will be performed; however, only one positive result is required for eligibility.
  • Estrogen/progesterone receptor positive OR negative disease allowed.
  • Patients must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Patients that have failed at least one anti-HER2 therapy in the metastatic setting.
  • Patients must have normal organ and marrow function as defined below:
    • absolute neutrophil count ≥ 1,500/mL;
    • platelets ≥ 100,000/mL;
    • total bilirubin ≤ institutional upper limit of normal (ULN);
    • aspartate aminotransferase (AST)/alanine aminotransferase (ALT) 5 ≤ X institutional ULN;
    • creatinine ≤ institutional ULN OR creatinine clearance ≥ 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Baseline left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiogram (preferred) or multigated acquisition (MUGA) scans.
  • Willing and able to comply with the requirements of the protocol.
  • Patient is able to take oral medication.
  • Signed informed consent.
  • Female patients of childbearing potential must be willing to use one highly effective form of hormonal contraception or two effective forms of nonhormonal contraception.
  • Contraception must continue for the duration of study treatment and for 7 months after the last dose of study treatment. The above contraception is not a requirement in the case of any of the following:
    • The patient, or partner of the patient, is surgically sterilized;
    • The female patient is > 45 years of age and is postmenopausal (has not menstruated for at least 12 consecutive months;
    • The patient truly abstains from sexual activity and when this is the preferred option to avoid conception and contraception and/or usual lifestyle of the patient.


Exclusion Criteria:

  • Metastatic breast cancer patients who are HER2 positive and have NOT progressed on at least one prior HER2-targeted therapies for metastatic disease -Patients who have not recovered from CTCAE, v. 4.03 grade 2 or higher toxicities of prior therapy to the point that they would be appropriate for re-dosing will be ineligible for study treatment. Subjects receiving weekly therapy must have a washout period from prior chemotherapy of as least one week. Washout period for chemotherapy administered every 2, 3, or 4 weeks will be 2, 3, and 4 weeks respectively, provided subject has recovered from toxicities of prior therapy such that retreatment is appropriate.
  • Patients must be at least two weeks from prior RT.
  • Patients must have a one-week washout period from prior hormonal therapy (e.g., testosterone, estrogen, progestin, gonadotropin-releasing hormone antagonist).
  • Patient has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging [using the identical imaging modality for each assessment, either MRI or CT scan] for at least 4 weeks prior to the first dose of study treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not been using steroids for at least 7 days prior to study treatment. Carcinomatous meningitis precludes a patient from study participation regardless of clinical stability. No concurrent anti-cancer treatment of any type.
  • Patients with known germline BRCA 1 or BRCA 2 mutations.
  • Patient has undergone prior treatment with a known poly(ADP-ribose) polymerase (PARP) inhibitor.
  • Prior treatment of a total doxorubicin > 360 mg/m^2 (or equivalent).
  • Patient has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid [HCV RNA] [qualitative] is detected).
  • Patient has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies). -Chronic immunosuppressive therapies including systemic corticosteroids or concurrent short-term use of immunosuppressive therapies is not allowed. Short- term corticosteroid use must be discontinued at least 2 weeks prior to study treatment.
  • Patients with known grade 2 or greater allergic reactions attributed to compounds of similar chemical or biological composition to niraparib are ineligible for study enrollment.
  • Patients with known grade 2 or greater allergic reactions attributed to compounds of similar chemical or biological composition to herceptin are ineligible for study enrollment.
  • Patient is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment. -History of non-breast malignancies within the 5 years prior to study entry, except for the following:
    • Carcinoma in situ (CIS) of the cervix;
    • CIS of the colon;
    • Melanoma in situ;
    • Basal cell and squamous cell carcinomas of the skin.
  • Patient is considered a poor medical risk due to a serious, uncontrolled medical disorder, nonmalignant systemic disease or active infection that requires systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study (including obtaining informed consent).
  • Cardiopulmonary dysfunction as defined by any of the following prior to randomization:
    • History of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.0) Grade ≥3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II;
    • Angina pectoris requiring anti-angina medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease -High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 [Mobitz 2] or third degree AV-block]);
    • Significant symptoms (Grade ≥ 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia;
    • Myocardial infarction within 12 months prior to randomization.
  • Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg).
  • Evidence of transmural infarction on ECG.
  • Heart-rate corrected QT interval (QTc) prolongation > 470 msec at screening.
  • Requirement for oxygen therapy.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

 

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Voice Signal Analysis to Screen for Depression and Anxiety in Patients with Persistent Post-COVID symptoms (Voila)

Voice Signal PASC Study

Ryan Hurt
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306059-H01-RST
21-010198
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Inclusion Criteria:

  • Aged 18 years of age or older.
  • Patients who have had a recent episode of COVID-19 who present to the post COVID-19 clinic.
  • Access to smartphone (iOS or Android operating systems).
  • Ability to complete study questionnaires and provide voice samples using a smartphone application.


Exclusion Criteria:

  • Known history of voice disorder either primary or secondary to neuromuscular or other pathology.
  • Cognitively impaired patients.
  • Unstable cardiovascular or pulmonary diseases.
  • History of seizures.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

Anxiety disorder, Coronavirus disease 2019, Depression, General infectious diseases, General mental illness, Generalized anxiety disorder
COVID-19, Chronic post-COVID-19 syndrome, Disease caused by 2019 novel coronavirus, Generalized anxiety disorder, Major depressive disorder, Post-acute COVID-19, Respiratory system
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ARST2031, A Randomized Phase 3 Trial of Vinorelbine, Dactinomycin, and Cyclophosphamide (VINO-AC) Plus Maintenance Chemotherapy With Vinorelbine and Oral Cyclophosphamide (VINO-CPO) vs Vincristine, Dactinomycin and Cyclophosphamide (VAC) Plus VINO-CPO Maintenance in Patients With High Risk Rhabdomyosarcoma (HR-RMS) (ARST2031)

A Study to Compare Early Use of Vinorelbine and Maintenance Therapy for Patients With High Risk Rhabdomyosarcoma

Wendy Allen-Rhoades
All
up to 50 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306069-P01-RST
21-010248
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Inclusion Criteria:

  • Patients must be ≤ 50 years of age at the time of enrollment.
  • Patients with newly diagnosed RMS of any subtype, except adult-type pleomorphic, based upon institutional histopathologic classification are eligible to enroll on the study based upon Stage, Group, and age, as below. FOXO1 fusion status must be determined by week 4 (day 28) of therapy. RMS types included under embryonal RMS (ERMS) include those classified in the 1995 International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the 2020 World Health Organization (WHO) Classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant). Classification of alveolar RMS (ARMS) in the 2020 WHO Classification is the same as in the ICR and includes classic and solid variants.
  • ERMS -Stage 4, group IV, ≥ 10 years of age.
  • ARMS -Stage 4, group IV Patients will be eligible to remain on protocol therapy based upon stage, group, and age.
  • Bone marrow metastatic disease is based on morphologic evidence of RMS based on hematoxylin and eosin (H&E) stains. In the absence of morphologic evidence of marrow involvement on H&E, patients with bone marrow involvement detected ONLY by flow cytometry, reverse transcriptase (RT)-polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or immunohistochemistry will NOT be considered to have clinical bone marrow involvement for the purposes of this study.
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR)  7 ≥ 0 mL/min/1.73 m^2; or
  • A serum creatinine based on age/gender as follows:
    • Age | Maximum serum creatinine (mg/dL)
    • 1 month to < 6 months | 0.4 mg/dL (male); 0.4 mg/dL (female);
    • 6 months to < 1 year 0.5 mg/dL (male) | 0.5 mg/dL (female);
    • 1 to < 2 years 0.6 mg/dL (male) | 0.6 mg/dL (female);
    • 2 to < 6 years 0.8 mg/dL (male) | 0.8 mg/dL (female);
    • 6 to < 10 years 1 mg/dL (male) | 1 mg/dL (female);
    • 10 to < 13 years; 1.2 mg/dL (male) | 1.2 mg/dL (female);
    • 13 to < 16 years; 1.5 mg/dL (male) | 1.4 mg/dL (female);
    • ≥ 16 years; 1.7 mg/dL (male) | 1.4 mg/dL (female).
    • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR39 utilizing child length and stature data published by the CDC.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  • If there is evidence of biliary obstruction by tumor, then total bilirubin must be < 3 x ULN for age.
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.


Exclusion Criteria:

  • Patients with evidence of uncontrolled infection are not eligible.
  • RMS that is considered a second malignancy and previous cancer(s) that were treated with chemotherapy and/or radiation. Surgical resection alone of previous cancer(s) is allowed.
  • Patients with central nervous system involvement of RMS as defined below:
    • Malignant cells detected in cerebrospinal fluid;
    • Intra-parenchymal brain metastasis separate and distinct from primary tumor (i.e., direct extension from parameningeal primary tumors is allowed);
    • Diffuse leptomeningeal disease;
    • Patients who have received any chemotherapy (excluding steroids) and/or radiation therapy for RMS prior to enrollment;
    • Note: the following exception:
    • Patients requiring emergency radiation therapy for RMS. These patients are eligible, provided they are consented to ARST2031 prior to administration of radiation.
    • Note: Patients who have received or are receiving chemotherapy or radiation for non-malignant conditions (e.g., autoimmune diseases) are eligible. Patients must discontinue chemotherapy for non-malignant conditions prior to starting protocol therapy.
  • Vincristine and vinorelbine are sensitive substrates of CYP450 3A4 isozyme. Patients must not have received drugs that are moderate to strong CYP3A4 inhibitors and inducers within 7 days prior to study enrollment.
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.

Eligibility last updated 9/29/21. Questions regarding updates should be directed to the study team contact.

Drug, Biologic/Vaccine, Radiation
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A051902: A Randomized Phase II Study of CHO(E)P vs CC-486-CHO(E)P vs Duvelisib-CHO(E)P in Previously Untreated CD30 Negative Peripheral T-Cell Lymphomas

Testing the Addition of Duvelisib or CC-486 to the Usual Treatment for Peripheral T-Cell Lymphoma

Nabila Bennani
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-306080-P01-RST
21-010262
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Inclusion Criteria:

  • Histologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) with < 10% CD30 expression by immunohistochemistry in the following subtypes (by local review): nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (TFH-PTCL), follicular T-cell lymphoma, PTCL-not otherwise specified (NOS), angioimmunoblastic T-cell lymphoma (AITL), enteropathy associated T-cell lymphoma, monomorphic epitheliotropic intestinal T-cell lymphoma.
  • Patients will be stratified by presence or absence of TFH phenotype (i.e., diagnosis of AITL, TFH-PTCL, follicular T-cell lymphoma) based on local review of pathology. Determination of TFH phenotype can be defined by expression of two or more of the following markers CD10, BCL6, CXCL13, ICOS, and PD1 by immunohistochemistry.
  • Measurable disease as defined by the Lugano criteria.
  • No prior systemic therapy for lymphoma (excluding corticosteroids).
  • Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to registration is required.
  • Age ≥ 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Platelet count ≥ 75,000/mm^3 (≥ 50,000/mm^3 if secondary to bone marrow involvement from lymphoma per investigator assessment; the first 12 patients on each arm of the study must have platelets ≥ 75,000/mm^3 regardless of bone marrow involvement).
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3.
  • Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN) * Except in subjects with documented liver involvement by lymphoma.
  • Calculated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula.
  • Total bilirubin ≤ 2.0 x ULN * Except in cases of Gilbert's Syndrome or documented liver or pancreatic involvement by lymphoma.
  • Archival tissue must be available for submission.
  • No active viral infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C. Those who are seropositive (e.g., hepatitis B core antibody [Ab] positive) are permitted if they are negative by polymerase chain reaction (PCR). Those who are seropositive for hepatitis B and are negative for hepatitis B virus (HBV) deoxyribonucleic acid (DNA) by PCR must receive concomitant hepatitis B directed antiviral therapy. Those who have hepatitis C Ab positivity who have completed curative therapy for hepatitis C with negative hepatitis C PCR are eligible.
  • Patients with history of HIV are eligible if they have an undetectable viral load for at least 6 months.
  • No active uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and/or other treatment).
  • Patients with Epstein-Barr virus (EBV) viremia related to their lymphoma are permitted.
  • Patients must have documented left ventricular ejection fraction of ≥ 45%.
  • No significant active cardiac disease within the previous 6 months including: 
    • New York Heart Association (NYHA) class III or IV congestive heart failure;
    • Unstable angina or angina requiring surgical or medical intervention; and/or
    • Myocardial infarction.


Exclusion Criteria:

  • Patients with expression of CD30 in ≥ 10% of the tumor (based on local immunohistochemistry review) regardless of histology will not be permitted.
  • Patients with a diagnosis of other PTCL subtype histologies other than those specified in the inclusion criteria are excluded including large cell transformation of mycosis fungoides.
  • Patients known to have HTLV 1/2.
  • Patients with known central nervous system involvement.
  • No concurrent malignancy requiring active therapy within the last 3 years with the exception of basal cell carcinoma limited to the skin, squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapy for cancer previously treated for curative intent is permitted.
  • No contraindication to any drug in the chemotherapy regimen, including neuropathy ≥ grade 2.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

Eligibility last updated 9/30/21. Questions regarding updates should be directed to the study team contact.

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Analysis of Patients with Polyuria as a Manifestation of Paroxysmal Atrial Tachyarrhythmias (ATACHPOLY)

Analysis of Fast Atrial Rhythm Manifesting with Increased Urination

Allan Jaffe
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306085-H01-RST
21-010267
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Inclusion Criteria:

  • Age 18 or older.
  • Patients with paroxysmal atrial tachyarrhythmias with and without polyuria as a manifestation of their tachyarrhythmia episode.
  • Documentation of their paroxysmal atrial tachyarrhythmia episode.


Exclusion Criteria:

  • Patients who are unable to manage the logistics of participating in the study (coming to Saint Mary’s Hospital ot have their blood drawn and urine sample collected during their atrial tachyarrhythmia episode).
  • Chronic kidney disease stage 4 or higher.
  • Clinical history of heart failure.

Eligibility last updated 10/1/21. Questions regarding updates should be directed to the study team contact.

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Detection of the Occurrence of Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence

James Pipe
All
18 years and over
This study is NOT accepting healthy volunteers
2021-306089-H01-RST
21-010301
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Inclusion Criteria:

  • Patients undergoing a MR brain without and with contrast examination on any GE or Siemens 1.5T and 3T MRI system within Mayo Clinic, Rochester, as part of their care plan.


Exclusion Criteria:

  • None.

Eligibility last updated 9/30/21. Questions regarding updates should be directed to the study team contact.

 

 

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A Phase 1/1b Open-Label Dose Escalation and Expansion Study of Bcl-2 Inhibitor BGB-11417 in Patients With Mature B-Cell Malignancies

Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

Wei Ding
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306097-P01-RST
21-013100
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Key Eligibility Criteria:

  • Provision of signed and dated written informed consent prior to any study specific procedures, sampling, or analyses.
  • Age 18 years or older.
  • Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following:

Note: For R/R cohorts, patients who have only received 1 line of therapy must be otherwise ineligible for, or intolerant to, available standard-of-care options.

NHL Cohorts:

a. MZL

i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least 1 prior therapy;
ii. Active disease requiring treatment.

b. FL i. R/R follicular lymphoma (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy ii. Active disease requiring treatment.
c. DLBCL

i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy);
ii. Active disease requiring treatment.

d. Transformed indolent B-cell NHL

i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter’s transformation) are not eligible for Part 1;
ii. Active disease requiring treatment MCL Cohorts:

e. WHO-defined MCL

i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy;
ii. Requiring treatment in the opinion of the investigator.

CLL/SLL Cohorts:

f. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia criteria (Hallek et al 2008):

i. Meeting the following sets of prior treatment criteria:

(1) For R/R cohorts (Cohorts 1B, 1C, 2C, 2D, 2E, 3A, and 4A), disease that relapsed after, or was refractory to, at least 1 prior therapy.
For the venetoclax-treated cohort (Cohort 2E): prior therapy history must include progression after a therapy containing ≥ 2 months of venetoclax treatment (monotherapy or combination).
(2) For the treatment-naïve cohorts (Cohorts 3C and 4B), patients should have no prior treatment for CLL/SLL (other than 1 aborted regimen < 2 weeks in duration and > 4 weeks before enrollment).

Note: TN CLL/SLL patients will only be enrolled at investigational sites where this is allowed by regulatory authorities/local ethics.

ii. Requiring treatment WM Cohorts:

g. WHO-defined WM (clinical and definitive histologic diagnosis)

i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy

ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström’s Macroglobulinemia (Dimopoulos et al 2014)

4. Measurable disease by computed tomography/magnetic resonance imaging, defined as:

a. CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes on flow cytometry.
b. DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1 extranodal lesion > 1.0 cm in the longest diameter, measurable in 2 perpendicular dimensions. For MZL isolated splenomegaly is considered measurable for this study. For MCL, clonal lymphocytes measured by flow cytometry is considered measurable.
c. WM: serum IgM level > 0.5 g/dL.

Key


Exclusion Criteria:

  • Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
  • Underlying medical conditions that, in the investigator’s opinion, will render the administration of study drug hazardous or obscure the interpretation of safety or efficacy results.
  • Known central nervous system involvement by lymphoma/leukemia.
  • Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter’s syndrome.
  • Prior autologous stem cell transplant unless ≥ 3 months after transplant; or prior chimeric antigen receptor T-cell (CAR-T) therapy unless ≥ 3 months after cell infusion.
  • Prior allogeneic stem cell transplant with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.
  • History of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention.

Eligibility last updated 9/12/22. Questions regarding updates should be directed to the study team contact.

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Phase 2 Clinical Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS) (FITCATS)

Trial of FIsetin to Treat CArpal Tunnel Syndrome (FITCATS)

Peter Amadio
All
45 years to 80 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-306106-H01-RST
21-010406
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Inclusion Criteria:

  • Adult men and post-menopausal women between age 45 and 80.
  • Symptoms of numbness or tingling for at least 4 weeks in at least two digits on one hand that include thumb, index, long, or radial border of ring finger.
  • Classic or probable carpal tunnel syndrome on Katz-Stirrat hand diagram.
  • A clinical diagnosis of carpal tunnel syndrome.
  • Able to complete English-language questionnaires and clinical evaluations.


Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • Previous carpal tunnel release on the study hand.
  • History of steroid injection into carpal tunnel or surgery on the affected wrist within the past 6 months.
  • Currently take a steroid medication either regularly or on as needed basis.
  • Currently taking warfarin (medication can be safely held during the following times:
    • Immediately before the 1st IP administration (Day 0) until at least 10 hours after the 2nd IP administration (Day 1);
    • Immediately before the 3rd IP administration (Day 29) until at least 10 hours after the 4th IP administration (Day 30).
  • Patient currently taking Sirolimus, Tacrolimus, or other mTOR inhibitors for other indications (mainly chronic indications represented by organ transplantation or autoimmune diseases).
  • Drugs listed as part of the exclusion criteria are not permitted during each of the two 2-day courses of treatment with Fisetin. If patients are required to initiate these medications within the 2-day period then they will be removed from the study primarily due to risk of drug-drug interaction.
  • Any of the following clinical diagnoses or conditions:
    • Cervical radiculopathy; 
    • Renal failure (see below);
    • Liver disease (see below);
    • Taking warfarin;
    • Peripheral nerve disease;
    • Uncontrolled diabetes (see below); or
    • Other metabolic disorder (as per clinical judgement).
  • The following laboratory tests as indicated or as per clinical judgement:
    • fasting plasma glucose > 200 as a marker of poor diabetic control;
    • CBC w/diff with Hgb < 12 as a marker of poor nutrition, creatinine > 2.5 as a marker of advanced kidney disease;
    • AST > 100 as a marker of liver disease;
    • Bilirubin > 2.0 as a marker of liver disease;
    • Cystatin c > 3 as a marker of advanced kidney disease;
    • A1c > 8 as a marker of poor diabetic control;
    • CRP > 10 as a marker of systemic inflammation;
    • ESR > 25 as a marker of systemic inflammation.
  • Prisoners, institutionalized individuals, or others who may be considered vulnerable populations, such as individuals with dementia.
  • Women of child-bearing potential.

Eligibility last updated 2/25/22. Questions regarding updates should be directed to the study team contact.

 

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A Phase 3, Multicenter, Prospective, Randomized, Double-blind, Efficacy and Safety Study of Rezafungin for Injection Versus the Standard Antimicrobial Regimen for the Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (The ReSPECT Study) (ReSPECT)

Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation (ReSPECT)

Paschalis Vergidis
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-306121-P01-RST
21-012795
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Inclusion Criteria:

  • Willing and able to provide written informed consent.
  • Males or females, ≥ 18 years of age.
  • Receiving a human leukocyte antigen (HLA) matched allogeneic peripheral BMT from a family or unrelated donor, HLA-mismatched related or unrelated donor, or haploidentical donor.
  • Diagnosed with 1 of the following underlying diseases:
    • Refractory anemia;
    • Refractory anemia with ringed sideroblasts;
    • Refractory cytopenia with multilineage dysplasia;
    • Refractory cytopenia with multilineage dysplasia and ringed sideroblasts;
    • Refractory anemia with excess blasts
      •1 (5-10% blasts);
    • Refractory anemia with excess blasts
      •2 (10-20% blasts);
    • Myelodysplastic syndrome, unclassified;
    • Myelodysplastic syndrome associated with isolated del (5q);
    • Chronic myelomonocytic leukemia;
    • Lymphoma (including Hodgkin's) with chemosensitive disease (i.e., response to chemotherapy) and receiving a related donor transplant;
    • Aplastic anemia;
    • Primary or secondary myelofibrosis.
  • Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission.
  • Acute lymphoblastic leukemia, in first or second complete remission.
  • Acute undifferentiated leukemia in first or second remission.
  • Acute biphenotypic leukemia in first or second complete remission.
  • Chronic myelogenous leukemia in either chronic or accelerated phase.
  • One of the following myelodysplastic syndrome(s) defined by the following:
    • Receiving myeloablative or reduced-intensity conditioning regimens.
  • Adequate renal and hepatic function, within 6 weeks of initiation of conditioning, as measured by:
    • Hepatic (within 72 hours of Day 0): alanine aminotransferase;
    • Renal (within 72 hours of Day 0): Serum creatinine within normal range for age or if serum creatinine above ULN range for age, a creatinine clearance [CrCl]) ≥60 mL/min.;
    • Baseline blood samples drawn for serum Platelia galactomannan enzyme immunoassay (GM EIA) and β-D glucan levels within 14 days before randomization, with results available prior to randomization;
    • Baseline Toxoplasma serologies available within 6 weeks prior to randomization;
    • Baseline glucose-6-phosphate dehydrogenase (G6PD) deficiency testing with no evidence of G6PD deficiency performed within 6 weeks prior to randomization.
  • Female subjects of child-bearing potential < 2 years post-menopausal must agree to and comply with using 1 barrier method (e.g., female condom with spermicide) plus one other highly effective method of birth control (e.g., oral contraceptive, implant, injectable, indwelling intrauterine device, vasectomized partner), or sexual abstinence while participating in this study. Male subjects must be vasectomized, abstain from sexual intercourse, agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm while participating in the study and for 120 days from the last IV dose of study drug.


Exclusion Criteria:

  • Diagnosis of AML not in morphological remission.
  • Diagnosis of chemotherapy-resistant lymphoma.
  • Suspected or diagnosed invasive fungal disease (IFD) within 4 weeks of screening.
  • Diagnosed symptomatic heart failure with left ventricular ejection fraction (LVEF) at rest ≤ 40%, LVEF > 40% but fails to improve with exercise, or shortening fraction ≤ 26%.
  • Personal or family history of Long QT interval on ECG (QT) syndrome or a prolonged QT interval corrected (QTc) interval (> 470 msec in males and > 480 msec in females); or concurrent administration of terfenadine, cisapride, astemizole, erythromycin, pimozide, or quinidine.
  • Diagnosed reduced lung function with either diffusion capacity (corrected for hemoglobin), forced expiratory volume 1, forced vital capacity ≤ 45% of predicted value, or O2 saturation ≤ 85% on room air.
  • Suspected or documented PCP within 2 years of screening.
  • Positive baseline serum Platelia GM EIA (≥ 0.5) and/or β-D glucan assay (≥ 80 pg/mL).
  • Receipt of previous allogeneic BMT.
  • Planned receipt of cord blood for transplantation.
  • Planned peripheral blood or marrow autograft.
  • Underlying diagnosis of multiple myeloma.
  • Grade 2 or higher ataxia, tremor, motor neuropathy, or sensory neuropathy, per NCI CTCAE version 5.0.
  • History of severe ataxia, neuropathy or tremors; or a diagnosis of multiple sclerosis or a movement disorder (including Parkinson's disease or Huntington's disease).
  • Planned or ongoing therapy at screening with a known neurotoxic medication for a complete list of prohibited neurotoxic medications).
  • Known hypersensitivity to Rezafungin for Injection, any echinocandin, fluconazole, posaconazole, other azole antifungal, or to any of their excipients.
  • Known hypersensitivity or inability to receive TMP/SMX or any of its excipients.
  • Recent use of an investigational medicinal product within 28 days of the first dose of prophylactic study drug or presence of an investigational device at the time of screening.
  • Known infection with HIV.
  • Pregnant or lactating females.
  • The Principal Investigator (PI) determines that the subject should not participate in the study.
  • Considered unlikely to follow up for 90 days after receipt of the BMT due to logistic concerns (i.e., location relative to transplant center).

Eligibility last updated 10/5/21. Questions regarding updates should be directed to the study team contact.

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A PhAse 1a/b, Dose finding, open-label study to eValuate sAfety and toxicity, of iNtravesiCal instillation of TARA-002 in adults with high-gradE non-muscle invasive blaDder cancer (ADVANCED-1)

Safety and Toxicity Study of Intravesical Instillation of TARA-002 in Adults with High-grade, Non-muscle Invasive Bladder Cancer

Paras Shah
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-306123-P01-RST
22-000182
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Inclusion Criteria:


- Male or female subjects 18 years of age or older at the time of signing the informed
consent

- Subjects who have voluntarily given written informed consent after the nature of the
study has been explained according to applicable requirements prior to study entry

- Subjects with a histologically confirmed, high-grade Ta or CIS (including CIS with
concomitant Ta) urothelial cell carcinoma of the bladder on central review

- Subjects who are treatment naïve, are unable to obtain intravesical BCG for the
treatment of NMIBC, have received at least one dose of intravesical BCG, or at least
one dose of intravesical chemotherapy


Exclusion Criteria:


- Penicillin allergy (subjects with a questionable history of allergy to penicillin or
no history of penicillin use will undergo penicillin blood allergy testing prior to
inclusion in the study)

- Predominant (defined as > 50%) adenocarcinoma, squamous cell carcinoma, or
histological variants including plasmacytoid, sarcomatoid, or squamous components
according to central review

- Concomitant prostatic or upper tract urothelial involvement, per Investigator's
assessment

- Nodal involvement or metastatic disease that existed at any time (past or present
disease)

- Bladder cancer stage ≥ T1 within the last 36 months according to central histology
review

- Bladder cancer stage CIS with concomitant T1

For more information on eligibility criteria, please contact the sponsor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/13/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine
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A Study Comparing Bi-parametric MRI to Multi-parametric MRI in the Diagnosis of Clinically Significant Prostate Cancer (PRIME)

Prostate Imaging Using MRI +/- Contrast Enhancement

Lance Mynderse
Male
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306129-P01-RST
21-011273
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Inclusion Criteria:

  • Men at least 18 years of age referred with clinical suspicion of prostate cancer.
  • Serum PSA ≤ 20ng/ml.
  • Fit to undergo all procedures listed in protocol.
  • Able to provide written informed consent.


Exclusion Criteria:

  • Prior prostate biopsy.
  • Prior treatment for prostate cancer.
  • Prior prostate MRI on a previous encounter.
  • Contraindication to MRI.
  • Contraindication to prostate biopsy.
  • Unfit to undergo any procedures listed in protocol.

Eligibility last updated 10/5/21. Questions regarding updates should be directed to the study team contact.

Diagnostic Test
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Physiological Regulation of Energy Intake - The FOOD-PRINT Study Identifying the Hormonal and Neural Footprints of the Visceroceptive, Homeostatic, and Hedonic Components of Food Intake Regulation in Humans (FOODPRINT)

Studying the Hedonic and Homeostatic Regulation of Food Intake using Functional MRI

Andres Acosta
All
21 years to 50 years old
Not Applicable
This study is NOT accepting healthy volunteers
2021-306140-P01-RST
21-010514
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Inclusion Criteria:

  • BMI 18-25 kg/m^2.
  • Age > 21 and < 50 years.
  • Weight stable for 3 months prior to study entry.
  • For females: study days will be scheduled during the follicular phase of their menstrual cycle (i.e., the first 13 days (about 2 weeks) of the cycle).
  • Able to provide written informed consent prior to any study procedures and be willing and able to follow study procedures.
  • Ability to perform light to moderate physical activity.


Exclusion Criteria:

  • Any contraindication for MRI scanning.
  • Any history of childhood (> 95th percentile) or adult obesity (BMI >30 kg/m^2).
  • Claustrophobia.
  • High intensity training or physical activity.
  • Any contraindication for intragastric balloon insertion.
  • Any allergies to the study meals.
  • Any history of eating disorder.
  • Any substance abuse disorder (including alcohol and tobacco).
  • Any history of psychiatric disorders.
  • Any cardiovascular, endocrine, pulmonary, neurological, or gastrointestinal comorbidities.
  • Pregnancy or nursing.
  • Any history of bariatric surgery or endoscopic bariatric procedure.
  • Use of any medication or supplement that alters appetite.
  • Patient has a known history of any condition or factor judged by the investigator to prevent participation in the study or which might hinder study adherence.

Eligibility last updated 10/6/21. Questions regarding updates should be directed to the study team contact.

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A Phase 3, Randomized, Double-blind, Two-period, Crossover, Withdrawal Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II) (AVTX-803)

A Study to Assess the Efficacy and Safety of AVTX-803 in Subjects with Leukocyte Adhesion Deficiency Type II (LAD II)

Eva Morava-Kozicz
All
6 months to 75 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-306143-P01-RST
21-010539
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Inclusion Criteria:


- Subject must be between 6 months and 75 years old

- Subject has biochemically and genetically proven LAD II (SLC35C1-CDG)

- Subject has a documented history of Lewis antigen deficiency

- Subject has a history of recurrent infections, opportunistic infections or infections
that did not respond well to standard of care treatment

- Subject or parent (for subjects under legal age for consent) has provided written
informed consent for this study. Additionally, written informed assent has been
provided, as appropriate, for minors of older age, per local institutional review
board (IRB)/ethics committee (EC) policy and requirements

- Subject is willing and able to comply with the protocol

- Women of childbearing potential (WOCBP) meeting the criteria below:

1. Non-lactating and has a negative pregnancy test at screening -AND-

2. Uses an acceptable double-barrier method of contraception as determined by the
investigator or sub-investigator for the duration of the study and 30 days
following the last dose of study drug.

- Male subjects must agree to use an acceptable double-barrier method of contraception
with their partner as determined by the investigator or sub-investigator for the
duration of the study and 30 days following the last dose of study drug.


Exclusion Criteria:


- Subject has severe anemia defined as hemoglobin <8.0 g/dL (<4.9 mmol/L)

- Subject has impaired renal function as defined by an eGFR <90 mL/min

- Subject has a total absence of fucosylation on red blood cells and the presence of
anti-H antigen

- Subject has known or suspected intolerance or hypersensitivity to fucose or any
ingredients of the investigational product

- In the investigator's opinion, subject has a history of failure to respond to fucose
at adequate dosing

- In the investigator's opinion, subject is not able or not willing to comply with the
study requirements.

- Subject is pregnant

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

Drug
Leukocyte adhesion deficiency - type 2, fucose
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ASCEND-ARDS in Children and ECMO Initiation Strategies Impact on Neuro-Development

ARDS in Children and ECMO Impact on Neuro-Development (ASCEND)

Jeffrey Weatherhead
All
14 days to 17 years old
This study is NOT accepting healthy volunteers
2021-306154-P01-RST
21-010577
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Inclusion Criteria:

  • Children aged 14 days
    •17 years.
  • At least moderate PARDS, bilateral lung disease, intubated within four days of severe PARDS and no exclusion criteria.


Exclusion Criteria:

  • Children will be excluded if they have any of the following at the start of mechanical ventilation: perinatal related lung disease, congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis, respiratory failure explained by cardiac failure or fluid overload, cyanotic heart disease, cardiomyopathy, unilateral lung disease, primary pulmonary hypertension, status asthmaticus (patient with a severe asthma exacerbation. A previous history of asthma or the use of bronchodilators is NOT an exclusion if the primary disease process is not considered to be obstructive airway disease), obstructive airway disease (e.g., severe airways disease without parenchymal involvement or disease characterized by hypercapnia with FiO2 < 0.30 and/or evidence of increased resistance visible on the flow – time scalar and/or presence of intrinsic PEEP),  bronchiolitis obliterans, post Hematopoietic Stem Cell Transplant, post lung transplant, home ventilator (including noninvasive) dependent, neuromuscular respiratory failure, critical airway (e.g., post laryngotracheal surgery or new tracheostomy) or anatomical obstruction of the lower airway (e.g., mediastinal mass), facial surgery or trauma in previous 15 days, head trauma, intracranial bleeding, unstable spine, femur or pelvic fractures, acute abdominal process/open abdomen, supported on ECMO, previously enrolled in current study, family/medical team deciding not to provide full support, enrolled in any other critical care interventional clinical trial concurrently and known pregnancy.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

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Advancing Prevention of Pulmonary Fibrosis - A Cohort Study of Preclinical Pulmonary Fibrosis (APPLe)

Advancing Prevention of Pulmonary Fibrosis

Teng Moua
All
40 years to 75 years old
This study is NOT accepting healthy volunteers
2021-306157-P01-RST
21-010596
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Inclusion Criteria:

  • Unaffected first degree relative from Familial Interstitial Pneumonia families (two or more family members with IIP).
  • Age at least 40 years old and younger than 75 years old.


Exclusion Criteria:

  • Diagnosed with known (physician-diagnosed) pulmonary fibrosis prior to informed consent.
  • Other genetic diseases associated with interstitial lung disease.
  • Pregnant women.

Eligibility last updated 10/7/21. Questions regarding updates should be directed to the study team contact.

 

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Investigation of Accuracy and Reliability of Tablet/iPhone-based Visual Acuity Test

Vision Testing Using iPad/iPhone

Cheryl Khanna
All
18 years and over
Phase 3, Feasibility
This study is NOT accepting healthy volunteers
2021-306164-P01-RST
21-010653
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Inclusion Criteria:

  • 100 subjects > 18 (200 eyes) with visual acuity at any level.

Exclusion Criteria:

  • Patients with no ability to sign the consent forms with no LAR.
  • Subjects with limited comprehension of English.

Eligibility last updated 10/18/21. Questions regarding updates should be directed to the study team contact.

 

 

 

Diagnostic Test, Device
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A Feasibility and Pilot Randomized Controlled Double-blind Trial of Intermittent Theta Burst Stimulation (iTBS) repetitive Transcranial Magnetic Stimulation (rTMS) to Improve Memory in Mild Cognitive Impairment (MCI) (iTBS rTMS in MCI)

iTBS rTMS in Mild Cognitive Impairment

Maria Lapid
All
18 years and over
Not Applicable, Feasibility
This study is NOT accepting healthy volunteers
2021-306168-H01-RST
21-010661
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Inclusion Criteria:


- Must speak English fluently

- Diagnosis of MCI as defined by:

- Clinical diagnosis by a neurologist

- Neuropsychological testing support of MCI

- Meet criteria for MCI

- Subjective cognitive decline reported by participant and/or an informant

- Objective memory impairment in one or more cognitive domains for age

- Essentially preserved general cognitive function

- Largely intact functional activities

- Does not meet criteria for dementia as judged by a clinician

- Eligible for transcranial magnetic stimulation (TMS) based on safety criteria

- Clinical Dementia Rating=0.5

- Geriatric Depression Scale score less than 6

- Medically stable and in good general health

- Not pregnant, lactating, or of childbearing potential

- Stable medication regimen for at least 4 weeks prior to baseline visit

- Adequate visual and auditory abilities to complete neuropsychological testing

- Ability to provide informed consent

- Have a care partner who is available to accompany the participant to study visits for
the duration of the protocol.


Exclusion Criteria:


- Inability to communicate in the English language

- Meet criteria for dementia

- Contraindications to TMS or MRI, including patients who have

- conductive, ferromagnetic or other magnetic-sensitive metals implanted in their
head or within 30 cm of the treatment coil (e.g., cochlear implants, implanted
electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments or
jewelry)

- active or inactive implants, including deep brain stimulators, cochlear implants,
vagus nerve stimulators or implanted device leads

- Any true positive findings on the TMS safety screening form

- Prior exposure to TMS, electroconvulsive therapy (ECT), or any neurostimulation within
the past 12 months

- History of epilepsy or seizures

- Medical conditions or use of medications that increase risk of seizures

- History of traumatic brain injury

- History of intracranial mass or lesion

- History of stroke, including hemorrhagic stroke and ischemic stroke

- Medications associated with seizures (Examples: Analgesics
•Opioids (e.g.,
meperidine, tramadol); Anti-amyloid immunotherapy such as aducanumab;
Antimicrobials
•Carbapenems (e.g., imipenem), Cephalosporins (fourth
generation), Fluoroquinolones (e.g., ciprofloxacin), Isoniazid, Penicillins;
Hypoglycemic agents; Immunosuppressants
•Azathioprine, Cyclosporine,
Mycophenolate, Tacrolimus; Psychiatric medications
•Antipsychotics, Atomoxetine,
Bupropion, Buspirone, Lithium, Monoamine oxidase inhibitors; Pulmonary drugs -
Aminophylline, Theophylline; Stimulants
•Amphetamines, Methylphenidate;
Sympathomimetics and decongestants
•Anorexiants (e.g., diethylpropion,
phentermine, nonprescription diet aids), Phenylephrine, Pseudoephedrine.)

- Psychiatric disorders

- Primary psychotic disorder (schizophrenia, schizoaffective, or schizophreniform
disorder), any history

- Primary mood disorder (major depressive disorder, bipolar disorder) within the
past 12 months

- Substance use disorder (except caffeine and nicotine) within the past 12 months

- Active symptoms of depression, anxiety, mania, psychosis, or substance use (except
caffeine and nicotine) within the past year

- Active symptoms of depression will be identified based on geriatric depression
scale ≥ 6

- Other active symptoms of psychiatric conditions to be determined by study
investigators

- Sleep disorders that are considered clinically significant and not sufficiently
treated by the investigative team, including untreated obstructive sleep apnea
(apnea-hypopnea index >15), untreated/suboptimally treated REM sleep behavior
disorder, untreated/suboptimally treated restless legs syndrome

- Pregnancy or suspected pregnancy

- Participation in another concurrent interventional clinical trial

- Any unstable medical condition

- Inability to provide informed consent

- Inability to adhere to the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/15/22. Questions regarding updates should be directed to the study team contact.

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EArLy FeasibiLity Study Of the EdWards Transcatheter Atrial Shunt System (ALt FLOW US) (ALt FLOW US)

Early Feasibility Study - Transcatheter Atrial Shunt System

Trevor Simard
All
18 years and over
Not Applicable, Early Feasibility
This study is NOT accepting healthy volunteers
2021-306204-P01-RST
21-010797
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Inclusion Criteria:


1. Signed and dated IRB approved study consent form prior to study related procedures

2. ≥ 18 years old

3. Chronic symptomatic Heart Failure (HF) documented by the following:

1. NYHA class II with a history of NYHA class > II; NYHA class III; or ambulatory
NYHA class IV AND

2. ≥ 1 HF hospital admission (with HF as the primary, or secondary diagnosis); or
treatment with intravenous (IV) or intensification of oral diuresis for HF in a
healthcare facility (emergency department/acute care facility) within the 12
months prior to study entry; OR an NT-pro BNP value > 150 pg./ml in normal sinus
rhythm, > 450 pg./ml in atrial fibrillation, or a BNP value > 50 pg./ml in normal
sinus rhythm, > 150 pg./ml in atrial fibrillation within the past 6 months.

4. In the judgment of the investigator, subject is on stable Guideline Directed Medical
Therapy (GDMT) for heart failure and management of potential comorbidities according
to current ACCF/AHA Guidelines and that is expected to be maintained without change
for 3 months

5. Elevated LA (or PCWP) pressure of > 15 mmHg at rest or > 25 mmHg during supine
ergometer exercise stress test, as measured at end-expiration; AND the LA (or PCWP)
exceeds right atrial pressure (RAP) by > 5 mmHg at rest or > 10 mmHg during supine
ergometer exercise stress test as measured at end-expiration

6. Willing to attend study follow-up assessments for up to 5 years

Inclusion Criteria for RV Overload group only:

I1B. Pulmonary Hypertension (PH) that maybe reversible, documented by the following:

1. Pulmonary Vascular Resistance (PVR) > 4 Wood Units at rest AND

2. Mean Pulmonary Artery Pressure (mPAP) ≥ 25 mmHg at rest AND

3. Successful reversibility of PH under a resting Sodium Nitroprusside challenge where
success is defined as a lowering of the PVR by ≥ 20% to a level < 4 Wood Units while
maintaining a Systolic Blood Pressure ≥ 90 mmHg


Exclusion Criteria:


1. Severe heart failure defined as one or more of the below:

1. ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF

2. If BMI < 30, Cardiac index < 2.0 L/min/m2

3. If BMI ≥ 30, cardiac index < 1.8 L/min/m2

4. Inotropic infusion (continuous or intermittent) within the past 6 months

5. Patient is on the cardiac transplant waiting list

6. LVEF < 20%

2. Presence of significant valve disease defined by the site cardiologist as:

1. Mitral valve regurgitation defined as grade > 3+ MR or > moderate MS

2. Tricuspid valve regurgitation defined as grade > 2+ TR

3. Aortic valve disease defined as > 2+ AR or > moderate AS

3. MI and/or any therapeutic invasive cardiac procedure within past 3 months; or current
indication for coronary revascularization

4. Valve replacement or surgical annuloplasty within the past 12 months

5. Cardiac Resynchronization Therapy initiated, stroke or transient ischemic attack (TIA)
within the past 6 months

6. Hemodynamic instability within 30 days of scheduled implant procedure

7. Patient requiring surgery under general anesthesia for any reason within 30 days of
scheduled implant procedure

8. Clinically diagnosed hypertrophic obstructive cardiomyopathy, constrictive
pericarditis or other infiltrative cardiomyopathy (eg, hemochromatosis, sarcoidosis)

9. Has renal insufficiency as determined by creatinine (S-Cr) level > 2.5 mg/dL or
estimated-GFR < 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis

10. Significant hepatic impairment defined as 3× upper limit of normal of transaminases,
total bilirubin, or alkaline phosphatase

11. Performance of the 6 minute walk test with a distance <50m OR >600m

12. Subject is contraindicated to receive either dual antiplatelet therapy or warfarin
(analogue); or has a documented coagulopathy

13. Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be
adequately medicated

14. Known hypersensitivity to Nickel and/or Tantalum

15. In the judgment of the investigator, life expectancy <12 months for noncardiovascular
reasons

16. In the opinion of the investigator, the subject is not an appropriate candidate for
the study

17. Anatomy (including implantable devices) that is not compatible with the Edwards
Transcatheter Atrial Shunt System

18. Active endocarditis or infection within 3 months of scheduled implant procedure

19. Currently participating (e.g., undergoing trial specific exams/treatment/procedures)
in an investigational drug or device study. Note: trials requiring extended follow-up
for products that were investigational but have since become commercially available
are not considered investigational trials.

20. Patient is a current intravenous drug user

21. Positive serum pregnancy test in female subjects of child-bearing potential or nursing
mothers or planning on becoming pregnant during the duration of the trial

22. Patient is under guardianship

23. Known pre-existing shunting, determined to be clinically significant by the
investigator

24. (Not applicable to RV Overload group) Right ventricular dysfunction, defined by the
site cardiologist as:

1. More than mild RV dysfunction as estimated by TTE; OR

2. TAPSE <1.4 cm; OR

3. RV size ≥ LV size as estimated by TTE; OR

4. Echocardiographic or clinical evidence of congestive hepatopathy

25. Evidence of pulmonary hypertension with PVR >4 Wood units

Exclusion Criteria for RV Overload group only:

E1B. Propensity for increased Right ventricular dysfunction, defined by the site
cardiologist as:

1. More than moderate RV dysfunction as estimated by TTE; OR

2. TAPSE <1.2 cm; OR

3. RV size ≥ LV size as estimated by TTE; OR

4. Right Atrial Pressure (RAP) > 18 mm Hg; OR

5. Echocardiographic or clinical evidence of congestive hepatopathy;

Eligibility last updated 7/20/22. Questions regarding updates should be directed to the study team contact.

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Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial

Care Anywhere with Community Paramedics Program to Reduce Hospitalization

Rozalina McCoy
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-306210-H01-RST
21-010816
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Inclusion Criteria
•Aim 1:

  • Clinicians (physicians, Nurse Practitioners, Physician Assistants), nurses, community paramedics, administrators, care coordinators, and other stakeholders likely to be engaged in the CACP program.

Inclusion Criteria
•Aim 2:

  • Adults (age ≥ 18 years) who are:
    • Currently admitted to the ED, hospital; or are
    • In a pre-hospital setting but being considered for referral to the ED or hospital at Mayo Clinic Rochester, MN and Barron, WI but do not require hospital-level monitoring or care other than services that could be delivered by CPs in the ambulatory setting if such services were available to them.
  • Eligible participants have to reside within an approximately 40-mile radius of Rochester, MN or within the service radius of Barron, WI. 
  • Participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home. For the purposes of the trial, “residence” and “home” refer to the place where the participant will be physically located after clinic, ED, or hospital discharge, and can include a hotel or another housing arrangement (i.e., not only their permanent residence).

Inclusion Criteria
•Aim 3:

  • All community paramedics (up to 18), clinicians who referred participants enrolled in the CACP intervention arm (up to 100), administrators involved with the CACP program (up to 30), and Mayo Clinic Ambulance leaders (up to 20) will be surveyed. 
  • All community paramedics (up to 18), purposive sample of participants enrolled in the CACP intervention arm (up to 35), and a purposive sample of clinicians, administrators, administrators, and Ambulance leaders (up to 35) will be interviewed.
  • Patient participants will be purposively sampled to ensure diversity of geography, age, sex, race and ethnicity, and clinical diagnosis for CACP program referral. Clinician and administrator participants will be purposively sampled to ensure representation of different ED and hospital service lines and frequency of referrals to the CACP program.

Exclusion Criteria
•Aim 1:​​

  •  
  • ​​​No exclusion criteria.

Exclusion Criteria
•Aim 2:​​

  • Referring clinician believes the patient requires referral to the ED (for patients in the pre-hospital setting) or hospital admission (for patients in the ED or hospital)
  • Not meeting criteria outlined in the Community Paramedic Referral Guide
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Clinical, behavioral, or cognitive instability, determined by the referring clinician or the CACP service
  • Living conditions unsafe for CPs to enter (e.g., patient refuses to secure weapons or animals prior to CP’s arrival)
  • Enrolled in the trial during an earlier hospitalization or ED visit.

Exclusion Criteria
•Aim 3:​​

  • There will be no exclusion criteria for Aim 3 clinicians or other clinical or administrative stakeholders.
  • Patient participants will be excluded if they:
    • Have a communication barrier due to medical illness or cognitive impairment; or
    • Are seriously ill or hospitalized at the time of interview recruitment.

Eligibility last updated 3/16/22. Questions regarding updates should be directed to the study team contact.

 

Other, Behavioral
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