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2881 Study Matches

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Development of Upper Limb Motor Scale to Measure Quality of Movement and Body Awareness in Stroke (AFAS)

Ann Van de Winckel
avandewi@umn.edu
All
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03328468
STUDY00000821
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Inclusion Criteria:

• Females and males ages 18-99 years of age
• People with stroke who are medically stable with one or more ischemic or
• hemorrhagic stroke(s)
• left or right hemiplegia
• willing and able to attend a one-time behavioral testing session
• willing and able to sign consent to participate
• able to hear, read and comprehend instructions given during the study
• English speaking (or willing to work with a (student) translator)
Exclusion Criteria:

• cognitive impairment (Mini-mental State Exam-brief version, <13/16)
• contractures in the tested arm that would hinder testing arm movements
• adults lacking capacity to consent
• severe neglect, aphasia, apraxia
• other medical conditions that preclude participation
Other: Breathing Exercise
Stroke
Stroke
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University of Minnesota — Minneapolis, Minnesota Ann Van de Winckel, PhD, MS, PT - (avandewi@umn.edu)

Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa

The objectives of this investigation are to: a) cross-sectionally compare neural correlates of reward responsiveness to typically rewarding cues (i.e., enjoyable video clips) and disorder-specific cues (i.e., restrictive eating food choices) between AN-WR and NC groups; b) cross-sectionally specify the relationship between neural correlates of reward responsiveness to typically rewarding cues and disorder-specific cues and restrictive eating in AN-WR; and c) longitudinally identify the neural correlates of reward responsiveness that are associated with the risk of relapse among individuals with AN-WR in the 12 months following initial participation.

Ann Haynos
afhaynos@umn.edu
All
18 Years and over
This study is also accepting healthy volunteers
NCT03275545
STUDY00000818
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Inclusion Criteria:

• Age > 18 years old
• Current BMI > 18.5 kg/m2
• Ability to read and speak in English
• Right-handed
• Weight restored Anorexia Nervosa group: 1) DSM-5 diagnosis of AN in the past 6 months, with the exception of body image disturbance and intense fear of weight gain criteria; 2) BMI < 18.5 kg/m2 within past 6 months
Exclusion Criteria:

• Medical instability or current pregnancy
• Current substance use disorder, psychosis, or bipolar-I disorder
• Contraindication for fMRI
• History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
• Food allergy that cannot be accommodated through substitutions to the laboratory test meal
• Lacking capacity to consent
• Non-eating disorder Control group: Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
Other: No intervention
Anorexia Nervosa
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University of Minnesota — Minneapolis, Minnesota Jessie Dzombak - (jdzombak@umn.edu)

Concurrent Aerobic Exercise and Virtual Reality Cognitive Training (VRCT)

All
65 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02963415
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Inclusion Criteria:
1. Cognitive complaint (defined as answering yes to the question "Do you feel that your memory or thinking skills have gotten worse recently?) 2. Not engaging in aerobic exercise or cognitive training >2 days/week, 30 minutes a session in the past 3 months; 3. Age 65 years and older
Exclusion Criteria:
1. Resting heart rate > 100 or < 50 beats/min; 2. Dementia (self-report, diagnosis, or scoring <18 on the modified Telephone Interview for Cognitive Status; 3. Neurological or major psychiatric disorder since memory problem; 4. Significant diseases, symptoms, or other factors that make exercise unsafe 5. Current enrollment in another intervention study
Behavioral: Exergame
Preclinical Alzheimer's Disease
Subjective memory complaint
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University of Minnesota — Minneapolis, Minnesota Fang Yu, PhD - (yuxxx244@umn.edu)

A Closed-loop Assessment and Treatment Platform for Unipolar Depression and Anxiety

This study is a validation study to evaluate the acceptability and feasibility of the closed-loop strategy employing the mobile mental health application with the target population to prepare for a large-scale efficacy trial in adults with MDD, depression and/or anxiety.

Gamze Camsari
gbalci@umn.edu
All
18 Years to 60 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02948036
STUDY00004179
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Inclusion Criteria:
1. Participant must be 18 to 60 years of age. 2. Participant must score ≥ 9 on the Patient Health Questionnaire-9 (PHQ-9). 3. Participant taking antidepressants or engaged in psychotherapy will not be excluded. If potential participants are currently prescribed psychotropic medication, they must be on a clinically stable medication regimen for ≥ 6 weeks prior to screening, based on self-report or as verified by medical health records, when available and authorized. 4. Participant must be a fluent English speaker. 5. Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control and use a mobile device and/or computer as required to complete study activities. 6. Participant must have access to wireless Internet connectivity. 7. Participant must be willing to communicate with study staff via email.
Exclusion Criteria:
1. Participant with unstable and/or untreated conditions that may affect cognition, including untreated substance abuse/dependence disorders, unmanaged cardiovascular disease, endocrine or neurologic disorder, epilepsy, brain injury, hospitalization within 6-weeks of enrollment, ongoing chemotherapy or other cancer treatment (e.g., radiation) . 2. Participant with history or current DSM-5 diagnosis of psychosis, such as schizophrenia, schizoaffective disorder, delusion disorder, psychotic disorder NOS, bipolar disorder, substance abuse (<1 year), and/or mood congruent or mood incongruent psychotic features or disorders. 3. Participant has a history or current diagnosis of dementia and/or scores less than a 14 (75%) on the UBACC. 4. Participant with active suicidal ideations or behaviors within 2 months of screening. 5. Participant that shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit. Such participants will have that visit re-scheduled; participants with this problem occurring more than once may be excluded and dropped at the discretion of the Principal Investigators. 6. Participant has problems performing assessments or comprehending or following spoken instructions, or those with behaviors during screening or baseline visits that, in the judgment of the screening staff, are likely to present significant problems for the staff conducting assessments. 7. Participant is enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment that could affect the outcome of this study. However, participation in standard treatments (e.g., occupational therapy) or use of prescribed medications (e.g., anti-depressants) is allowable.. 8. Participant is using computer-based cognitive training programs or has used it within a month of the consent date.
Other: Mobile-device, plasticity-based adaptive cognitive treatment
Major Depressive Disorder
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University of Minnesota — Minneapolis, Minnesota Sasha Mochida - (mmtstudy@umn.edu)

Measurement of Glucose Metabolism in Humans: Effect of Recurrent Hypoglycemia on Hypothalamic GABA (GABA)

The purpose of this study is to determine the effects of altered glucose metabolism on the brain. For example, patients with long duration diabetes mellitus lose their ability to secrete the hormones necessary to protect them against hypoglycemia, which may be due to alterations in glucose availability to the human brain.

All
18 Years to 65 Years old
N/A
This study is also accepting healthy volunteers
NCT02829593
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Inclusion Criteria:

• well controlled type 1 diabetes (hemoglobin A1c <7.5%)
• age 18-65
• healthy controls
Exclusion Criteria:

• history of stroke, seizures, neurosurgical procedures, or arrhythmias
• use of drugs that can alter GABA metabolism (such as benzodiazepines).
• Subjects must also meet requirements for a study in the magnet, which includes weight less than 300 lbs and the absence of metallic substances in their body.
Other: hypoglycemia (low blood sugar) and MRI
Type 1 Diabetes, Healthy
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University of Minnesota — Minneapolis, Minnesota Anjali Kumar, PA-C - (studydiabetes@umn.edu)

The LoBAG Diet and Type 2 Diabetes Mellitus

Randomized clinical trial investigating the LoBAG diet versus a control diet for treatment of type 2 diabetes mellitus over a 3 month intervention period.

Anne Bantle
bant0015@umn.edu
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02717078
1601M82501
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Inclusion Criteria:

• 18 years of age or older
• Diagnosis of type 2 diabetes mellitus
• Hemoglobin A1c of 7.0-9.5%
• Taking no medications for diabetes or taking metformin
Exclusion Criteria:

• Type 1 diabetes mellitus
• Treatment with insulin
• BMI < 27 kg/m^2
• Change in weight of more than 5 pounds in the prior 3 months
• Estimated glomerular filtration rate (GFR) < 60 ml/minute/1.73 m^2
• Urine albumin > 300 mg/g creatinine
• Anemia
• Pregnancy or immediate plans to become pregnant
• Current breast feeding
• Use of antibiotics in the 3 month period prior to study enrollment
• Dietary restriction(s) that would preclude consumption of the study diets
• Inability or unwillingness to prepare meals
• Presence of any disease which would make adherence to the study protocol difficult
Other: Diet Therapy
Type 2 Diabetes Mellitus
diet, carbohydrate, protein, glucose, type 2 diabetes mellitus
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University of Minnesota — Minneapolis, Minnesota Anne Bantle - (d-study@umn.edu)

Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)

Gaucher disease is the most common lysosomal storage disorder due to a mutation in the lysosomal enzyme, glucocerebrosidase. There is increasing evidence that oxidative stress and/or inflammation contribute to the pathophysiology. In order to evaluate oxidative stress and/or inflammation in patients with Gaucher disease, we will analyze a series of blood biomarkers and correlate them with currently used diagnostic biomarkers of this condition. We will determine oxidative stress and/or inflammation related biomarkers in whole blood and/or plasma in adult subjects with Gaucher disease. Fifteen milliliter blood sample will be collected during three independent visits over a period of approximately 3 months. These samples will be processed to separate plasma from red blood cells and frozen until assays are performed. Standardized immunoassay methods and LC/MS based methods will be adopted to assay a series of biomarkers in these samples. These data will be correlated with currently used diagnostic biomarkers.

All
18 Years to 75 Years old
This study is NOT accepting healthy volunteers
NCT02437396
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Inclusion Criteria:
1. All participants must be 18 years or older. 2. All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent. 3. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator. 4. GD subjects should be stable on a specific ERT and/or SRT therapy at a specific dose (at least 2 years) or be naïve to these therapies (no therapy for 2 years).
Exclusion Criteria:
1. Medically unstable conditions in any group as determined by the investigators 2. Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception 3. History of asthma that is presently being treated or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment 4. Patients who cannot or are unwilling to have blood drawn 5. Unable to adhere to study protocol for whatever reason
Gaucher Disease Type I, Oxidative Stress
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University of Minnesota — Minneapolis, Minnesota Reena Kartha, PhD - (rvkartha@umn.edu)

Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

The proposed pilot study is a randomized controlled study to assess the effectiveness of transcranial Direct Current Stimulation (tDCS) to enhance cognitive remediation therapy (CRT) in patients with psychotic illnesses. We will determine whether any observed changes in symptoms and cognition are greater in participants who receive concurrent tDCS and cognitive remediation therapy as compared to individuals who receive sham stimulation. Additionally, we will determine whether there are functional changes in participants who received active vs. sham tDCS by comparing EEG data from both groups.

Ian Ramsay
ramsa045@umn.edu
All
18 Years to 64 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02085421
1311M45305
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Inclusion Criteria:
1. Meet diagnostic criteria for schizophrenia or schizoaffective disorder 2. Are age 18-64 3. Fluent in written and spoken English 4. Have an outpatient status of at least 1 month prior to participation 5. Has been on a stable dose of psychiatric medication for at least one month prior to participation
Exclusion Criteria:
1. History of seizures or epilepsy 2. Metallic cranial plates, screws, or implanted devices 3. History of craniotomy 4. History of stroke 5. History of eczema on scalp 6. Pre-existing sores or lesions at sites of tDCS electrode placement 7. Non removable facial piercings 8. Current or possibility of current pregnancy 9. Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months
Device: tDCS
Psychosis
tdcs, neuromodulation, CRT, psychosis, schizophrenia
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University of Minnesota — Minneapolis, Minnesota Ian S Ramsay, PhD - (ramsa045@umn.edu)

Alport Syndrome Treatments and Outcomes Registry (ASTOR)

The Alport Syndrome Treatments and Outcomes Registry (ASTOR) was founded in 2007 with the goal of facilitating clinical trials of new treatments for the disease. Because Alport syndrome is a rare disorder, rapid recruitment of sufficient participants for meaningful therapeutic trials will be greatly enhanced by pre-existing patient registries.

All
up to 99 Years old
This study is NOT accepting healthy volunteers
NCT00481130
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Inclusion Criteria:
History of a diagnosis of Alport syndrome, Family or individuals need to be able to comprehend the consent and HIPAA forms written in the English language.
Exclusion Criteria:
Uncertain diagnosis of Alport syndrome.
Alport Syndrome
Alport Syndrome, x linked, autosomal dominant Alport syndrome, glomerular basement membrane, hereditary nephritis, familial benign haematuria, type IV collagen, hereditary nephritis with neurosensory deafness, vison loss
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University of Minnesota — Minneapolis, Minnesota

Observational Study of Solid Organ Transplantation Utilizing HIV-Positive Donors in HIV-Positive Recipients

This is a prospective, observational study designed to evaluate the safety of solid organ transplantation using HIV-positive deceased donors (liver, kidney) and HIV-positive living donors (liver) in HIV-positive recipients.

Timothy Pruett
tlpruett@umn.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT03170414
1608M93841
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RECIPIENT ELIGIBILITY CRITERIA HIV-Positive Recipient Inclusion Criteria (liver, kidney) 1. Participant is able to understand and provide informed consent. 2. Participant meets standard listing criteria for transplant. 3. Documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or documented history of detectable HIV-1 RNA). 4. Participant is ≥ 18 years old. 5. No evidence of active opportunistic complications of HIV infection. 6. Participant CD4+ T-cell count is >/= 200/µL within 16 weeks prior to transplant for kidney transplant recipients. For liver transplant recipient, CD4+ T-cell counts need to be >/= 100/ul (or >/= 200/µL if history of opportunistic infection) within 16 weeks prior to transplant. 7. Participant most recent HIV-1 RNA < 50 copies/mL (by any FDA-approved assay performed in CLIA-approved laboratory), in the 26 weeks prior to transplant. Participants unable to tolerate ART due to organ failure or who have only recently started ART may have detectable viral load and still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation. 8. Concurrence by the study team that based on medical history and ART, viral suppression can be achieved in the recipient post-transplant. 9. No history of primary CNS lymphoma or progressive PML. 10. On a stable antiretroviral regimen. Participants unable to tolerate ART due to organ failure may still be considered eligible if the study team is confident there will be a safe, tolerable, and effective antiretroviral regimen once organ function is restored after transplantation. HIV-Positive Recipient Exclusion Criteria (liver, kidney) 1. Participant has concomitant conditions that, in the judgment of the investigators, would preclude transplantation or immunosuppression. DONOR ELIGIBILITY CRITERIA HIV-Positive Deceased Donor (liver, kidney) 1. Must meet all clinical criteria for HIV-uninfected organ donors. 2. No evidence of invasive opportunistic complications of HIV infection. 3. Pre-implant donor organ biopsy showing no disease process that would put the recipient at increased risk of rapid progression to end-stage organ failure, to be stored for the duration of the study. 4. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. 5. If known history of HIV infection and prior antiretroviral therapy, the study team must describe the anticipated post-transplant antiretroviral regimen to be prescribed for the recipient and justify its conclusion that the regimen will be safe, tolerable and effective. HIV-Positive Living Donor (liver) 1. Donor meets all clinical criteria to be a living liver donor other than being HIV positive. 2. Donor has documented HIV infection (by any licensed ELISA and confirmation by Western Blot, positive HIV ab IFA, or history of detectable HIV-1 RNA) from a CLIA-approved laboratory. 3. No evidence of invasive opportunistic complications of HIV infection 4. Donor CD4+ T-cell count is >/= 500/µL in the 26 weeks prior to donation. 5. The most recent HIV-1 RNA has been below 50 copies RNA/ml in the 26 weeks prior to donation. 6. On a stable antiretroviral regimen. 7. Must be evaluated by the HIV/Transplant Infectious Diseases team to verify resistance history and current ART regimens. The potential for transmission of resistant strain of HIV will be assessed. 8. Pre-implant donor liver biopsy to be stored for the duration of the study showing no evidence of a disease process that would put the donor at increased risk of progressing to end-stage organ failure after donation, or that would present a risk of poor graft function to the recipient. 9. Must be evaluated by an independent HIV study living donor advocate separate from the transplant service in addition to the living donor advocate seen by all living donors.
HIV, Awaiting Organ Transplant
HIV, Kidney Transplant, Liver Transplant, Transplant, HOPE Act
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University of Minnesota Medical Center — Minneapolis, Minnesota Timothy Pruett, M.D.

Circuit-Based Deep Brain Stimulation for Parkinson's Disease; Udall Project 1 Aim 2 and 3

Study objectives: -To characterize spontaneous and movement-related LFP changes in STN and GP in externalized patients under conditions that modulates the severity of tremor, bradykinesia and rigidity (off meds/off stim; on meds/off stim; off meds/on stim, on meds/on stim). -To characterize and compare the relative effect of different forms of closed loop stimulation (e.g., triggered at specific thresholds of low beta/HFO PAC or beta band activity) to standard isochronal high frequency DBS on motor signs and performance during movement.

Michael Park
mcpark@umn.edu
All
22 Years to 85 Years old
This study is NOT accepting healthy volunteers
NCT03079037
1701M04144
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Inclusion Criteria:

• Diagnosis of idiopathic PD
• A history of a good response to levodopa (carbidopa/levodopa) defined as at least a 30% improvement in motor UPDRS score
• DBS surgery or IPG battery replacement at UMN is planned as part of routine clinical care.
Exclusion Criteria:

• Other significant neurological disorder
• History of dementia
• Prior history of stereotactic neurosurgery
• Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
• Pregnant women
Device: Stimulation
Parkinson Disease
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University of Minnesota Medical Center — Minneapolis, Minnesota Michael C. Park, MD/PhD - (mcpark@umn.edu) Kelly Ryberg, MA - (rybe0010@umn.edu)

Bartonella in Liver Transplant Patients

All
18 Years and over
This study is NOT accepting healthy volunteers
NCT02595710
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Inclusion Criteria:

• o Male and female subjects, ages 18 years and older
• Liver transplant recipient
• Diagnosis of cryptogenic cirrhosis
• Signed consent form
Exclusion Criteria:

• none
Other: skin punch biopsy collection, Other: Blood collection, Other: Urine sample collection
Cryptogenic Cirrhosis, Cryptogenic Chronic Hepatitis
Cryptogenic Chronic Hepatitis, Bartonellosis
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University of Minnesota Medical Center — Minneapolis, Minnesota Marna E Ericson, phd - (erics004@umn.edu)

Stress Reactivity as a Determinant in Co-occurring Alcohol Use and Anxiety Disorder: Diagnosis and Alcohol Use Outcomes

Comorbid AUD+AnxD is a significant barrier to successful AUD treatment. Converging evidence implicates overlap in dysregulation of systems governing stress response (HPA, ANS, CNS) for symptom development in AUD and AnxD. However, this must be systematically demonstrated in comorbid AUD+AnxD. We will assess markers of multi-system biological stress regulation (at rest and in response to laboratory challenge) in alcohol use disorder (AUD) inpatients with and without co-occurring anxiety disorder (AnxD), as well as those with AnxD who do versus do not receive a cognitive behavioral treatment that specifically targets comorbid AUD-AnxD. Laboratory measures include 1) cortisol (to assess the hypothalamic–pituitary–adrenal axis system [HPA] function; 2) heart rate variability (to assess autonomic nervous system [ANS] function), and 3) threat-potentiated startle (to assess central nervous system [CNS] function). Laboratory assessments will occur at the following times: 1) shortly after AUD treatment admittance (Visit 2: Pre-Treatment), 2) immediately following the 4-week AUD treatment (Visit 3: Post-Treatment), 3) 1 month following AUD treatment (Visit 4: 1-Month Follow-Up), and 4) 4 months following AUD treatment (Visit 5: 4-Month Follow-Up). Self-reported alcohol intake will be assessed at baseline as well as at the 1- and 4-Month Follow-Ups to determine whether laboratory stress measures predict treatment outcomes. A single laboratory assessment of healthy controls will serve as a normative reference for characterizing patient laboratory responses in terms of dysregulation and re-regulation.

Justin Anker
anke0022@umn.edu
All
18 Years to 65 Years old
This study is also accepting healthy volunteers
NCT03056872
1612M02641
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Inclusion Criteria:

• Ability to provide informed consent
• Between the ages of 18 and 65
• Diagnostic and Statistical Manual diagnosis of a Panic Disorder, Generalized Anxiety Disorder, or Social Anxiety Disorder within the past 30 days (AUD+AnxD group only).
• Primary alcohol use disorder diagnosis and alcohol use in the 30 days preceding the study (AUD alone and AUD+AnxD groups only).
• Inpatient treatment at Lodging Plus primarily for alcohol (vs. other drug with nicotine accepted) dependence (AUD alone and AUD+AnxD groups only).
• A minimum of a sixth-grade reading level.
• Healthy controls, same criteria absent AUD and AnxD diagnosis of an alcohol and/or anxiety disorder
• Lives within proximity to the Twin Cities (e.g., within about an hour's drive) or willing to drive to Fairview for the purpose of attending follow-up visits
• Willingness to provide contact information to confirm follow-up appointments
Exclusion Criteria:

• Lifetime history of psychosis or mania
• Cognitive impairment, physical impairment, or chronic medical illness that precludes study participation
• Primary PTSD as determined by qualifying assessment
• Females currently pregnant
• Exposure to antipsychotic medication for a total duration >16 weeks.
• Prior head injury leading to >30 minutes of unconsciousness.
• Cognitive impairment that impedes study participation.
• Healthy controls with a history of any major medical or psychiatric disorders (e.g., schizophrenia, depression, heart disease, or stroke).
• Suicide intent or attempt in the past 30 days
• Cardiovascular health issues
• Thyroid Disease
• History of severe neurological illness such as chronic seizure disorder (e.g, epilepsy) or stroke
• Brain tumor and/or implants in the skull cavity (e.g., plate in the skull)
• Pacemaker
Alcohol Use Disorder, Anxiety Disorder/Anxiety State, Stress Disorder, Hypothalamic Pituitary Adrenal, Drinking to Cope
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University of Minnesota Fairview Riverside — Minneapolis, Minnesota Nikki Degeneffe - (stress-study@umn.edu)

Mapping Chemical and Microbiological Heterogeneity Throughout Explanted Cystic Fibrosis Lung Specimens

We propose to study explanted tissue of patients that are scheduled to undergo single or double lung transplant surgery as a late-stage disease therapeutic strategy. The primary endpoint will be to characterize the composition of the bacterial community in the lung. The secondary endpoint will be to describe bacterial gene expression in the lower airways.

Ryan Hunter
rchunter@umn.edu
All
18 Years and over
This study is NOT accepting healthy volunteers
NCT02128711
1404M49426
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Inclusion Criteria:

• diagnosis of cystic fibrosis
• eligible for lung transplantation
• exhausted other available therapies without success
• informed consent
Exclusion Criteria:

• there are no exclusion criteria
Cystic Fibrosis
lung, cystic fibrosis, bacteria, positive diagnosis of CF,
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University of Minnesota Medical School — Minneapolis, Minnesota Jordan Dunitz, MD - (dunit001@umn.edu)

FT538 in Subjects With Advanced Hematologic Malignancies

Mark Juckett
juck0001@umn.edu
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04614636
STUDY00010225
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Inclusion Criteria:
1. Diagnosis of one of the following by treatment regimen: Regimen A (FT538 monotherapy in r/r AML)
• Primary refractory AML, or
• Relapsed AML, defined as not in CR after one or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required Regimens B or C (FT538 + mAb in r/r MM)
• Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
• Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
• Regimen B and Regimen C: Measurable disease as defined in the protocol 2. Capable of giving signed informed consent 3. Age ≥18 years old 4. Agreement to comply with study procedures as described in the Schedule of Activities 5. Contraceptive use as described in the protocol
Exclusion Criteria:
1. Females who are pregnant or breastfeeding 2. ECOG Performance Status ≥ 2 3. Evidence of insufficient hematologic function as defined in the protocol 4. Evidence of insufficient organ function defined as defined by the protocol 5. Clinically significant cardiovascular disease as defined by the protocol 6. Known active central nervous system (CNS) involvement by malignancy 7. Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment 8. Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period 9. Clinically significant infections including HIV, HBV and HCV 10. Live vaccine <6 weeks prior to start of lympho-conditioning 11. Receipt of an allograft organ transplant 12. Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy 13. Known allergy to albumin (human) or DMSO 14. Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject 15. Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results Exclusion Criteria Specific to Regimen A (r/r AML) 16. Diagnosis of promyelocytic leukemia with t(15;17) translocation 17. Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1 Exclusion Criteria Specific to Regimens B and C (r/r MM) 18. Plasma cell leukemia defined as a plasma cell count >2000/mm3 19. Leptomeningeal involvement of MM 20. Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the first dose of mAb 21. Allergy or hypersensitivity to antibodies or antibody-related proteins
Drug: FT538, Drug: Cyclophosphamid, Drug: Fludarabine, Drug: Daratumumab, Drug: Elotuzumab
Acute Myeloid Leukemia, AML, Adult, Multiple Myeloma, Myeloma
Acute Myeloid Leukemia, AML, Multiple Myeloma, daratumumab, elotuzumab, NK cell, cellular therapy
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University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota

Umbilical Cord Blood Transplantation Using a Myeloablative Preparative Regimen for Hematological Diseases

This is a treatment protocol for an unrelated umbilical cord blood transplant (UCBT) using a myeloablative preparative regimen for the treatment of hematological diseases, including, but not limited to acute leukemias. There is no research element except the collection of routine clinical data.

Claudio Brunstein, MD
bruns072@umn.edu
All
up to 55 Years old
N/A
This study is NOT accepting healthy volunteers
NCT01962636
1305M34181
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Inclusion Criteria:

• Eligible Disease Status
• Acute Myeloid Leukemia (AML): high risk CR1 (as evidenced by preceding MDS, high risk cytogenetics, ≥ 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
• Very high risk pediatric patients with AML: Patients <21 years, however, are eligible with (M2 marrow) with < 25% blasts in marrow after having failed one or more cycles of chemotherapy.
• Acute Lymphocytic Leukemia (ALL): high risk CR1 as defined by cytogenetics (such as t(9;22), t (1:19), t(4;11), other MLL rearrangements, hypodiploidy, or IKZF1 abnormalities), DNA index < 0.81, > 1 cycle to obtain CR or presence minimal residual disease (MRD). Patients in CR2+ are eligible. All patients must be in CR as defined by hematological recovery, AND <5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%.
• Very high risk pediatric patients with ALL: patients <21 years are also considered high risk CR1 if they had M2 or M3 marrow at day 42 from the initiation of induction or M3 marrow at the end of induction. They are eligible once they achieved a complete remission.
• Chronic Myelogenous Leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate.
• Plasma Cell Leukemia after initial therapy, who achieved at least a partial remission
• Advanced Myelofibrosis
• Myelodysplasia (MDS) IPSS INT-2 or High Risk (i.e. RAEB, RAEBt) or Refractory Anemia with severe pancytopenia or high risk cytogenetics: Blasts must be < 10% by a representative bone marrow aspirate morphology.
• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Marginal Zone B-Cell Lymphoma or Follicular Lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission. Patients who had remissions lasting > 12 months, are eligible after at least two prior therapies. Patients with bulky disease (nodal mass greater than 5 cm) should be considered for de-bulking chemotherapy before transplant.
• Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia are eligible after initial therapy in CR1+ or PR1+.
• Large Cell NHL > CR2/> PR2: Patients in CR2/PR2 with initial short remission (<6 months) are eligible.
• Lymphoblastic Lymphoma, Burkitt's Lymphoma, and other high-grade NHL after initial therapy if stage III/IV in CR1/PR1 or after progression if stage I/II < 1 year.
• Multiple Myeloma beyond PR2: Patients with chromosome 13 abnormalities, first response lasting less than 6 months, or β-2 microglobulin > 3 mg/L, may be considered for this protocol after initial therapy.
• Myeloproliferative Syndromes
• Availability of suitable UCB unit(s)
• 0 to 55 years
• Voluntary written consent (adult or parental/guardian)
Exclusion Criteria:

• previous irradiation that precludes the safe administration of TBI
•Radiation Oncology will evaluate all patients who have had previous radiation therapy
• chemotherapy refractory large cell and high grade NHL (ie progressive disease after > 2 salvage regimens)
• if ≤ 18 years old, prior myeloablative transplant within the last 6 months. If >18 years old prior myeloablative allotransplant or autologous transplant
• extensive prior therapy including > 12 months alkylator therapy or > 6 months alkylator therapy with extensive radiation
• pregnant or breastfeeding
• HIV positive
Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Drug: Cyclosporine A, Drug: Mycophenylate mofetil, Biological: Umbilical cord blood
Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myelofibrosis, Myelodysplasia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Lymphoblastic Lymphoma, Burkitt's Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma
Umbilical Cord Transplant, Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myelogenous Leukemia, Plasma Cell Leukemia, Myelofibrosis, Myelodysplasia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Marginal Zone B-Cell Lymphoma, Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle-Cell Lymphoma, Prolymphocytic Leukemia, Large Cell Non-Hodgkin Lymphoma, Lymphoblastic Lymphoma, Burkitt's Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma
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University of Minnesota Masonic Cancer Center — Minneapolis, Minnesota Claudio Brunstein, MD - (bruns072@umn.edu)

Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies

This is a treatment study for a allogeneic hematopoietic stem cell transplantation (HSCT) in patients with sickle cell disease (SCD), thalassemia, Diamond Blackfan Anemia (DBA) and other non-malignant hematologic disorders that are transfusion dependent or represent other potentially life-threatening cytopenias. The objective of this study is to confirm the findings of our previous allogeneic hematopoietic stem cell transplant trial for non-malignant hematologic disorders that are transfusion dependent or represent other potentially life-threatening cytopenias including: • incidence of graft failure • disease free survival (DFS) including red cell transfusion independence at 6 months, 1 and 2 years • overall survival at 6 months, 1 and 2 years

Ashish Gupta
gupta461@umn.edu
All
up to 55 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02179359
1407M52125
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Inclusion Criteria:

• Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated
• Acceptable stem cell source identified
• Performance status of ≥ 70% (Karnofsky),or ≥ 70 (Lansky play score)
• Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children
• Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal
• Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%
Exclusion Criteria:

• active, uncontrolled infection
• pregnant or breastfeeding
• HIV positive
Drug: Reduced Toxicity Ablative Regimen, Drug: Reduced Intensity Preparative Regimen, Drug: Myeloablative Preparative Regimen
Sickle Cell Disease, Transfusion Dependent Alpha- or Beta- Thalassemia, Diamond Blackfan Anemia, Paroxysmal Nocturnal Hemoglobinuria, Glanzmann Thrombasthenia, Severe Congenital Neutropenia, Shwachman-Diamond Syndrome, Non-Malignant Hematologic Disorders
Stem Cell Transplant
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University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota Lisa Burke - (lburke3@Fairview.org)

Hematopoietic Stem Cell Transplant for Dyskeratosis Congenita or Severe Aplastic Anemia

This study facilitates the collection and analysis of outcome data for patients with dyskeratosis congenita (DC) or severe aplastic anemia (SAA) undergoing a hematopoietic stem cell transplant (HSCT). Specific transplant related endpoints include incidence of: -neutrophil engraftment at day 42 and platelet engraftment at 1 year -regimen related morality at 100 days -acute GVHD at 100 days -chronic GVHD at 6 months and 1 year -secondary malignancies

Christen Ebens
ebens012@umn.edu
All
up to 70 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02162420
1404M50183
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Inclusion Criteria:

• Aged 0
•70 years
• Acceptable hematopoeitic stem cell donor
• Dyskeratosis Congenita (DC) with evidence of BM failure defined as:
• requirement for red blood cell and/or platelet transfusions or
• requirement for G-CSF or GM-CSF or erythropoietin or
• refractory cytopenias having one of the following three
• platelets <50,000/uL or transfusion dependent
• absolute neutrophil count <500/uL without hematopoietic growth factor support
• hemoglobin <9g/uL or transfusion dependent
• Diagnosis of DC with a triad of mucocutaneous features:
• oral leukoplakia
• nail dystrophy
• abnormal reticular skin hyperpigmentation, or
• Diagnosis of DC with one of the following:
• short telomeres (under a research study)
• mutation in telomerase holoenzyme (DKC1, TERT, TERC, NOP10, NHP2, TCAB1)
• mutation in shelterin complex (TINF2)
• mutation in telomere-capping complex (CTC1)
• Severe Aplastic Anemia (SAA) primary transplant with evidence of BM failure:
• Refractory cytopenia defined by bone marrow cellularity <50% (with < 30% residual hematopoietic cells)
• Diagnosis of SAA with refractory cytopenias having one of the following three:
• platelets <20,000/uL or transfusion dependent
• absolute neutrophil count <500/uL without hematopoietic growth factor support
• absolute reticulocyte count <20,000/uL
• Severe Aplastic Anemia (SAA) requiring a 2nd transplant
• Graft failure as defined by blood/marrow chimerism of < 5%
• Early myelodysplastic features
• With or without clonal cytogenetic abnormalities
• Adequate organ function defined as:
• cardiac: left ventricular ejection fraction ≥ 35% with no evidence of decompensated heart failure
• pulmonary: DLCO ≥30% predicted, no supplemental oxygen requirement
• renal: Glomerular filtration rate (GFR) ≥30% predicted
• Voluntary written consent
Exclusion Criteria:

• Acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on biopsy
• Pregnant or lactating
• Uncontrolled infection
• Prior radiation therapy (applies to SAA patients only)
• Diagnosis of Fanconi anemia based on DEB
• Diagnosis of dyskeratosis congenita with advanced MDS or acute myeloid leukemia with >30% blasts
Drug: Alemtuzumab, Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Biological: Stem Cell Transplant, Drug: Anti-thymocyte globulin
Dyskeratosis Congenita, Aplastic Anemia
severe aplastic anemia, Hematopoietic Stem Cell Transplant
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University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota Timothy Krepski - (tkrepsk1@fairview.org)

Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

The objectives of this study are to assess the following: - Incidence of sustained donor engraftment at day 42 post transplant - Incidence of transplant related mortality (TRM) at day 100 - Overall survival at day 100 and 1 year - Acute GVHD after this second transplant at day 100 and 6 months - Chronic GVHD after this second transplant at day 12 and 24 months

Troy Lund
lundx072@umn.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT02161783
1404M49341
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Inclusion Criteria:

• Patients with primary or secondary graft failure, as defined below, may receive a second transplant:
• Primary graft failure is defined as not achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35
•42 following the first transplant.
• Secondary graft failure is defined as achieving an ANC ≥0.5x10^9/L for three consecutive days by day 35
•42, but subsequently drops below 0.5x10^9/L without recovery.
• Loss of chimerism is defined as achieving an ANC ≥0.5x10^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
• Recipients should have acceptable organ function defined as:
• Renal: creatinine < 2.0 (adults) and creatinine clearance > 30. For creatinine clearance < 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
• Hepatic: bilirubin, AST/ALT, ALP < 10 x upper limit of normal
• Cardiac: left ventricular ejection fraction > 40%
Exclusion Criteria:

• Uncontrolled infection at the time of transplant.
• Patients with Fanconi Anemia or other DNA breakage syndromes.
Drug: Fludarabine, Drug: Cyclophosphamide, Radiation: Total Body Irradiation, Biological: Hematopoietic stem cell infusion
Primary Graft Failure, Secondary Graft Failure
Hematopoietic stem cell transplant
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University of Minnesota Medical Center, Fairview — Minneapolis, Minnesota Timothy Krepski - (tkrepsk1@fairview.org)

University of Minnesota Transplant Registry

All
Not specified
This study is NOT accepting healthy volunteers
NCT01062581
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Inclusion Criteria:

• Received a transplanted organ at the University of Minnesota
• Living donor who donates an organ at the University of Minnesota
Exclusion Criteria:

• Did not receive a transplant at the University of Minnesota
• Did not donate an organ at the University of Minnesota
Transplant Recipient, Transplant Donation
Recipient, Donor, Organ Transplant, Registry, University of Minnesota
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University of Minnesota Transplant Information Services — Minneapolis, Minnesota Kathryn S Long, RN - (klong1@fairview.org)

Impact of Low Nicotine Cigarette Messaging on Perceptions and Cigarette Choices

The purpose of this research is to evaluate the effects of low nicotine content cigarette (LNC) educational messaging on perceptions of low nicotine cigarettes, tobacco/nicotine product choice preferences (hypothetical), LNC cigarette subjective ratings, and LNC cigarette abuse liability among adult smokers.

Dana Carroll
dcarroll@umn.edu
All
21 Years and over
Early Phase 1
This study is also accepting healthy volunteers
NCT04740008
STUDY00012495
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Inclusion Criteria:

• Male or female
• At least 21 years of age
• Biochemically confirmed smoker
Exclusion Criteria:

• Unstable health condition
• Unstable medications
• Pregnant or nursing
• Unreliable access to a computer, smart phone or tablet without working camera and internet access for telehealth visits and online questionnaires
Drug: Low Nicotine Content Cigarettes, Other: Control message, Other: Test message
Smoking, Cigarette
Low Nicotine Content, Educational Messaging, Cigarette, Smoking
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University of Minnesota, Tobacco Research Program, 717 Delaware St., SE — Minneapolis, Minnesota

FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia

This study is designed to find the maximum tolerated dose (MTD) of FT538 when given in combination with daratumumab for the treatment of acute myeloid leukemia (AML).

Joseph Maakaron
maaka001@umn.edu
All
12 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04714372
STUDY00012524
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Disease specific
Inclusion Criteria:
Acute myeloid leukemia relapsed/refractory after 2 lines of therapy; with CD38 expression
• CD38 expression is defined by ≥20% of malignant cells with CD38 expression by flow cytometry on the most recent marrow biopsy (within 30 days of enrollment
•archived or fresh).
• Relapsed/refractory is defined as failure to achieve at least a Morphological Leukemia Free State (MLFS) or reverting from MLFS.
• Lines of therapy are defined as (must have had 2 prior therapies):
• One cycle of Intensive induction chemotherapy such as 7+3, 5+2, MEC, FLAG, FLAG-Ida, CLAG ± small molecule inhibitor
• Four weeks of HMA-based induction ± small molecule inhibitor
• Hematopoietic stem cell transplantation (HSCT) if relapse that occurs > 90 days after HSCT
• Gemtuzumab Ozogamicin
• LDAC + glasdegib
• Biomarker-specific targeted agents (FLT3 inhibitors, IDH1/2 inhibitors, others if available)
• Other treatments could be considered after discussion with the PI
Inclusion Criteria:

• Age 12 years or older at the time of consent
•Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors.
• Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
• Karnofsky performance status of 80-100% for 16 years and older or Lansky Play Score of 80-100 for ≥12 and < 16 years of age
• Evidence of adequate organ function within 14 days of starting study treatment defined as:
• Estimated Glomerular Filtration Rate (estimated creatinine clearance) ≥50 mL/min/1.73m^2
• Total bilirubin ≤ 5 × upper limit normal (ULN), not applicable for patients with Gilbert's syndrome
• AST ≤3 × ULN and ALT ≤ 3 × ULN, not applicable if determined to be directly due to underlying malignancy
• LVEF ≥ 40% by echocardiogram or MUGA
• Contraceptive use by men or women
• Female subjects: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of cyclophosphamide (CY), at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
• Male subjects: Males with a female partner of childbearing potential or a pregnant female partner must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 4 months after the final dose of CY and at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
• Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
• Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
Exclusion Criteria:

• Diagnosis of acute promyelocytic leukemia (APL)
• Pregnant or breastfeeding, Menstruating females of child-bearing potential must have a negative pregnancy test within 14 days of study treatment start
• Known allergy to any of study drugs or their components
• Clinically significant cardiovascular disease including any of the following: myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher or cardiac ejection fraction <40%
• Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) during the FT538 dosing period (3 days before the 1st dose through 14 days after the last dose) excluding pre-medications
•inhaled and topical steroids are permitted
• Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the to the first dose of daratumumab. Maintenance hydroxyurea for blast control up to the initiation of lympho-conditioning is permitted
• Known active central nervous system (CNS) involvement or treated CNS disease that has not cleared. If prior disease related CNS involvement must have completed effective treatment of their CNS disease at least 2 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging
• Non-malignant CNS disease such as epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
• Clinically significant untreated/uncontrolled infection
• Live vaccine <6 weeks prior to start of lympho-conditioning
• Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR
• Prior solid organ transplant
• Allogeneic HSCT relapse occurring <90 days after HSCT
• Active graft-versus-host-disease (GvHD) requiring systemic immunosuppression within 14 days prior to enrollment
• Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to the participant.
Drug: Daratumumab/rHuPH20, Drug: FT538, Drug: Fludarabine, Drug: Cyclophosphamide
Acute Myeloid Leukemia, Myeloid Leukemia, Monocytic Leukemia
FT538, AML, Daratumumab, CD38
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Joseph Maakaron, MD - (maaka001@umn.edu)

Neurotoxicity Prophylaxis With Intrathecal Dexamethasone and Simvastatin Post Axi-Cel

Joseph Maakaron
maaka001@umn.edu
All
18 Years to 80 Years old
Early Phase 1
This study is NOT accepting healthy volunteers
NCT04514029
STUDY00009175
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Inclusion Criteria:

• 18- 80 years of age
• One of the following histologies:
• Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or
• Primary mediastinal B-cell lymphoma, or
• High grade B-cell lymphoma, or
• DLBCL arising from follicular lymphoma
• Disease status:
• Chemotherapy refractory disease after ≥2 lines of chemotherapy, or
• Relapsed with no remission after ≥1 lines of salvage chemotherapy, or
• Relapsed following autologous hematopoeitic stem cell transplantation (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post auto HCT, the subject must have no complete response, or relapse after the last line of therapy
• Performance Status
• ECOG performance status 0-2
• Adequate organ function defined as:
• Renal function defined as:
• eGFR ≥ 30 mL/min/1.73 m^2
• Liver function defined as:
• ALT and AST ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA
• Women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment as outlined in axi-cel protocol.
• Able to provide written voluntary consent (or LAR consent for adults with diminished capacity) prior to the performance of any research related tests or procedures
• Availability of a certified practitioner to perform the lumbar punctures
Exclusion Criteria:

• Allergies, or intolerance to simvastatin or dexamethasone
• Already receiving a statin drug for hypercholesterolemia and unwilling to change medication to 40 mg/day of simvastatin
• Active uncontrolled CNS lymphoma. Patients with history of CNS lymphoma who have been adequately treated are eligible
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD).
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection
• Unstable angina and/or myocardial infarction
• Risk factors that preclude a safe lumbar puncture (high intracranial pressure, bleeding diathesis that cannot be reversed or corrected, need for uninterrupted anticoagulation, platelets < 50K that cannot be corrected with transfusional support
• Pregnant or breastfeeding as agents used in this study are Pregnancy Category C (dexamethasone) and X (simvastatin). Females of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days of study registration.
Drug: Simvastatin, Drug: Dexamethasone
Lymphoma
Lymphoma, CAR-T, Neurotoxicity, CRS, Dexamethasone, Simvastatin
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Joseph Maakaron, MD - (maaka001@umn.edu)

A Study of Metastatic Gastrointestinal Cancers Treated With Tumor Infiltrating Lymphocytes in Which the Gene Encoding the Intracellular Immune Checkpoint CISH Is Inhibited Using CRISPR Genetic Engineering

This is a single center Phase I/II study to determine the safety of the administration of mutation reactive autologous lymphocytes with knockout of the CISH gene in adults with metastatic gastrointestinal epithelial cancer that have failed prior therapy.

Emil Lou
emil-lou@umn.edu
All
18 Years to 70 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT04426669
STUDY00007137
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Inclusion Criteria:

• Diagnosis of metastatic gastrointestinal epithelial cancer with progressive disease following at least one first line standard therapy. When available, archived tissue from original diagnosis will be obtained for research related testing.
• Must have measurable disease per RECIST 1.1 with at least one lesion identified as resectable for TIL generation (minimum volume of tumor tissue required is 1 cm^2 as single mass or fragments) and at least one other lesion meeting the RECIST criteria for measurable to serve as an indicator of disease response. The location of the tumor for TIL generation and method used to obtain (i.e. laparoscopy, endoscopic ultra sound, etc.) will be determined based on an individual patient's disease.
• Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible. Patients must not be receiving systemic steroids.
• Brain metastases are assessed using the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
• Age ≥ 18 years and ≤ 70 years.
• Clinical performance status of ECOG 0 or 1.
• Serology testing within 3 months of study enrollment (tumor collection):
• Seronegative for HIV antibody. (The investigational treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immunocompetence and thus may be less responsive to the study treatment and more susceptible to its toxicities.)
• Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.
• Seronegative for anti-HBc, HBV/HCV/HIV-1 NAT, anti-HTLV-I/II, anti-T.cruzi, West Nile Virus NAT, anti-CMV, and RPR. (Note: Other blood viral testing may be required as updated on the FDA website: https://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/TissueSafety/ucm095 440.htm#approved)
• Hematology within 14 days of study enrollment:
• Absolute neutrophil count > 1000/mm^3 without the support of filgrastim
• WBC ≥ 3000/mm^3
• Platelet count ≥ 75,000/mm^3
• Hemoglobin > 8.0 g/dl. Subjects may be transfused to reach this cutoff.
• Adequate organ function within 14 days of study enrollment defined as:
• Serum ALT and AST ≤ 5.0 x ULN
• Serum creatinine ≤ 1.6 mg/dl
• Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin ≤ 3.0 mg/dl.
• More than four weeks must have elapsed since prior systemic therapy at the time the patient receives the preparative regimen, and acute toxicities must have recovered to Grade 1 or less (except for toxicities such as alopecia or vitiligo). Disease appropriate standard therapy is permitted between tumor collection and start of the fludarabine and cyclophosphamide. Investigational therapy is prohibited. Note: Patients may have undergone minor surgical procedures within the 3 weeks of the start of preparative therapy as long as all toxicities have recovered to Grade 1 or less.
• Willing to undergo outpatient non-mobilized leukapheresis (3 hour collection) prior to the tumor collection
• Agrees to remain in the Twin Cities metropolitan area (within 1 hour drive of the University of Minnesota) after the CISH KO TILs infusion through the End of Treatment visit (Day 28)
• Voluntary written consent prior to the performance of any research related procedures
Exclusion Criteria:

• Pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant. Women of childbearing potential (defined as menses within previous 12 month and/or FSH ≤ 40 IU/L) must have a negative pregnancy test (serum or urine) within 7 days of enrollment. A repeat negative pregnancy test is required within 7 days of beginning the preparative chemotherapy.
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease).
• Concurrent opportunistic infection (The treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the treatment and more susceptible to its toxicities).
• Active systemic infections requiring anti-infective treatment, coagulation disorders or any other active major medical illnesses.
• Concurrent systemic steroid therapy.
• History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.
• History of coronary revascularization or ischemic symptoms.
• Documented LVEF ≤ 45% tested in patients:
• Age ≥ 65 years and/or
• With clinically significant atrial and/or ventricular arrhythmias, including but not limited to: atrial fibrillation, ventricular tachycardia, second- or third-degree heart block, or have a history of ischemic heart disease and/or chest pain. Patients < 65 years of age who present with cardiac risk factors (e.g., diabetes, hypertension, obesity) may undergo cardiac evaluation as noted above.
• Clinically significant patient history that in the judgment of the PI would compromise the patient's ability to tolerate high-dose aldesleukin.
• Documented FEV1 ≤ 50% predicted tested in patients with:
• A prolonged history of cigarette smoking (approximately 20 packs/year within the past 2 years) and/or
• Symptoms of respiratory dysfunction
• Receiving any investigational agents. Confirmation of Eligibility Prior to CY/FU Start: Due to a 10-12 week or more delay between study enrollment and the start of study treatment, the following eligibility criteria must be met:
• Clinical performance status of ECOG 0 or 1
• Hematology within 7 days of starting lymphodepleting chemotherapy:
• Absolute neutrophil count > 1000/mm^3 without the support of filgrastim
• WBC ≥ 3000/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin > 8.0 g/dl. Subjects may be transfused to reach this cutoff.
• Adequate organ function within 7 days of starting lymphodepleting chemotherapy:
• Serum ALT and AST ≤ 5.0 x ULN
• Serum creatinine ≤ 1.6 mg/dl
• Total bilirubin ≤ to 2.0 mg/dl, except in patients with Gilbert's Syndrome, who must have a total bilirubin ≤ 3.0 mg/dl.
• Seronegative for HIV antibody, hepatitis B antigen, and hepatitis C antibody as tested within 3 months of beginning lymphodepleting chemotherapy. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative
• More than four weeks must have elapsed since the last dose of prior systemic therapy and the start of the lymphodepleting chemotherapy, and acute toxicities must have recovered to Grade 1 or less (except for toxicities such as alopecia or vitiligo).
• Sexually active females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception for the duration of study treatment starting with the 1st dose of fludarabine and for 4 months after the last dose of aldesleukin. Examples of effective contraception includes an IUD or implant plus a condom. Women of non-childbearing potential are defined as those who have no uterus, ligation of the fallopian tubes, or permanent cessation of ovarian function due to ovarian failure or surgical removal of the ovaries. A woman also is presumed to be infertile due to natural causes if she has been amenorrheic for > 12 months and/or has an FSH > 40 IU/L.
• Negative pregnancy test within 7 days of starting lymphodepleting chemotherapy in women of childbearing potential.
• No change in medical status or social situation that would make study participation not in the best interest of the patient in the opinion of the enrolling investigator.
• Continues to agree to remain in the Twin Cities metropolitan area (within 1 hour drive of the University of Minnesota) after the CISH KO TILs infusion through the End of Treatment visit (Day 28)
• Voluntary signed the study treatment consent form within 28 days prior to the start of the lymphodepleting chemotherapy.
Drug: Cyclophosphamide, Drug: Fludarabine, Biological: Tumor-Infiltrating Lymphocytes (TIL), Drug: Aldesleukin
Gastrointestinal Epithelial Cancer, Gastrointestinal Neoplasms, Cancer of Gastrointestinal Tract, Cancer, Gastrointestinal, Gastrointestinal Cancer, Colo-rectal Cancer, Pancreatic Cancer, Gall Bladder Cancer, Colon Cancer, Esophageal Cancer, Stomach Cancer
Adoptive Cell Therapy, Immunotherapy, Gene Therapy, CISH checkpoint, CRISPR
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Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Dr. Emil Lou, MD, PhD

MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs

This is a single-institution, phase II study to determine the event-free survival at 1 year post allogeneic transplant with or without serial mesenchymal stem cell (MSC) infusions from a related donor (HLA identical, mismatched or haploidentical) or matched unrelated donor for the biochemical correction of severe epidermolysis bullosa (EB). A single marrow harvest is performed to collect the stem cells for the transplant procedure and, with the donor’s consent, the collection of an additional 40-50 ml sample for MSC production for post-transplant infusion on month (± 14 days) 2, 4, and 6; and additionally offered at 8 and 10 months. If the donor refuses to consent for the extra marrow collection, the patient will receive only the transplant. The patient will be enrolled, based on the donor’s consent to one of the following arms: Arm A: hematopoietic cell transplant alone using 300 cGY of TBI (closed to accrual) Arm B: hematopoietic cell transplant plus serial MSC infusions using 300 cGY of TBI (closed to accrual) Arm C: re-transplant using 300 cGy of TBI (regardless of original transplant arm) if <1 year from first BMT Effective with the November 2016 version of the protocol: Arm D: hematopoietic cell transplant alone using 200 cGY BID of TBI (400 cGy total) for recipients of 8/8 HLA-matched bone marrow Arm E: hematopoietic cell transplant plus serial MSC infusions using 200 cGY BID of TBI (400 cGy total) for recipients of 8/8 HLA-matched bone marrow Effective with the November 2018 version of the protocol: Arm F: hematopoietic cell transplant alone using 200 cGy BID of TBI (400 cGy total) + addition of low dose busulfan for recipients of HLA-mismatched bone marrow Arm G: hematopoietic cell transplant plus serial MSC infusions using 200 cGy BID of TBI (400 cGy total) + addition of low dose busulfan for recipients of HLA-mismatched bone marrow In event of graft failure (failure to engraft, autologous recovery or loss of graft), patients may be eligible for re-transplant on this study (Arm C) or through the University of Minnesota BMT protocol MT2013-06

Jakub Tolar, MD
tolar003@umn.edu
All
up to 25 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT02582775
1510M79481
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Inclusion Criteria:

• Diagnosis of severe form of EB characterized by collagen, laminin, integrin, keratin or plakin deficiency (by immunofluorescence staining with protein specific antibodies or Western blotting and by mutation analysis).
• Adequate organ function within 4 weeks of study registration defined as:
• Renal: glomerular filtration rate within normal range for age
• Hepatic: Hepatic: bilirubin, AST/ALT, ALP < 5 x upper limit of normal
• Pulmonary: adequate pulmonary function in the opinion of the enrolling investigator
• Cardiac: left ventricular ejection fraction ≥ 45%, normal EKG or approved by Cardiology for transplant
• Sexually active participants must agree to use adequate birth control for the during the study period (from before the start of the preparative chemotherapy through 1 year post-transplant)
• Available donor per section 5: targeted MFI < 1,000 (MFI exceeding 1000 must be approved by the PI and treatment team.)
• Voluntary written consent
•adult or parent (with information sheet for minors, if applicable) prior to any research related procedures or treatment
Exclusion Criteria:

• beta 3 laminin JEB mutants
• Active untreated systemic infection at time of transplantation (including active infection with Aspergillus or other mold within 30 days)
• History of HIV infection
• Evidence of squamous cell carcinoma
• Pregnant or breast feeding. Females of child-bearing potential must have a negative pregnancy test prior to study registration as the agents administered in this study are Pregnancy Category C and D.
Drug: Thymoglobulin, Drug: Cyclophosphamide, Drug: Fludarabine, Radiation: Total Body Irradiation, Procedure: Bone marrow infusion, Drug: Tacrolimus, Drug: Mycophenolate Mofetil, Biological: Donor mesenchymal stem cell infusions, Drug: Busulfan
Epidermolysis Bullosa
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University of Minnesota Masonic Cancer Center and Medical Center — Minneapolis, Minnesota Lisa Burke, RN - (lburke3@Fairview.org)

Adrenoleukodystrophy National Registry Study

In this protocol, we will enroll pediatric, adolescent and adult patients diagnosed with adrenoleukodystrophy (ALD). These patients will include probands diagnosed by newborn screening and their relatives subsequently diagnosed, as well other patients who are diagnosed with ALD due to other presenting signs and symptoms and subsequently were confirmed to have ALD. We will ask consenting subjects to provide a medical history (with verification via medical records), to participate in a semi-annual health survey and provide consent to collect biospecimens. The overarching goal of this work is to engage with families affected by ALD and to assemble a resource of clinical, medical, and biological data that will allow of to better understand the natural history of ALD, and how this is affected by newborn screening. The initial focus will be on patients within Minnesota, but participation will be open to any family interested in the study, as this will be web-based. This registry and biobank, together with other research conducted in tandem, will possibly provide information describing the natural history of ALD and outcomes with interventions. It is anticipated that the data collected will further our understanding of the natural history of the disease, basic biology of adrenoleukodystrophy, diagnosis and outcomes. Ultimately, this research may lead to new avenues for early diagnosis and development of safer and more effective therapies for ALD.

Ashish Gupta
gupta461@umn.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT03789721
STUDY00003605
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Inclusion Criteria
• Age 0
•100
• ALD patients or family member meeting any of the following criteria:
• Any patient diagnosed with ALD (confirmed by positive VLCFA testing and/or genetic mutation).
• Known or presumed mutation with ALD based on pedigree or confirmed mutation in ABCD1 gene
• Participants living in the United States and territories Exclusion Criteria
• Patients diagnosed with ALD who lack the capacity to consent/assent AND do not have a designated legally authorized representative or guardian.
• Patients who have undergone BMT or other cellular therapy .
• Patients not fluent in English who are unable to consent in-person at the BMT Journey Clinic.
• Patients who are illiterate
• Patient determined by the PI or designee to be unlikely to complete required study components (due to language barriers, compliance issues, etc.)
Other: Medical Record Abstraction, Other: Biospecimen Sample Collection
ALD (Adrenoleukodystrophy), Adrenoleukodystrophy, Cerebral Adrenoleukodystrophy
Registry, VLCFA, ABCD1, X-chromosome
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Phil Lacher - (placher@umn.edu)

MT2017-45: CAR-T Cell Therapy for Heme Malignancies

This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. The study provides criteria for consistent treatment and management according to FDA labelling of CAR-T products and does not contain experimental components. Patients will be assigned to Arms A B and C based on age, CAR-T product and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arms A B and C separately.

Veronika Bachanova, MD
bach0173@umn.edu
All
Not specified
This study is NOT accepting healthy volunteers
NCT03642626
STUDY00004096
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ARM A: Kymriah for Refractory/relapsed B-cell acute lymphoblastic leukemia expressing CD19
Inclusion Criteria:

• Age and Disease Status
• Must be age 0-25 years
• Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these:
• Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or
• Patients with persistent minimal residual disease (MRD >0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or
• Patients in 2nd or greater relapse of B-ALL or
• Patients with persistent CNS leukemia, or
• Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or
• Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory.
• Performance Status
• Karnofsky (age ≥16 years) or Lansky (age < 16 years) performance status ≥ 50% at screening
• ALC >500/uL at screening (prior to apheresis) and absolute lymphocyte count >/= 150/uL
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as: ** ALT ≤ 5 times the ULN for age (unless due to disease) ** Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Other Inclusion Criteria
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding
•Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
• CNS 2A
• CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment.
• Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1 ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma
Inclusion Criteria:

• Age and Disease Status
• Adult patients (age ≥ 18 years)Patients must be ≥18 years of age
• One of the following histologies and expression of CD19 by tumor cells: ** diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or ** primary mediastinal large B-cell lymphoma, or ** high grade B-cell lymphoma, or ** DLBCL arising from follicular lymphoma
• Disease status: ** Chemotherapy refractory disease after ≥2 lines of chemotherapy, or ** Relapsed with no remission after ≥1 lines of salvage chemotherapy, or ** Relapsed following autologous HCT (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post autoHCT, the subject must have no response or relapse after the last line of therapy
• Measurable disease at time of apheresis: Nodal lesions or extranodal lesion
• ECOG performance status 0-2
• ALC >/=100/uL at screening (prior to apheresis)
• Renal function defined as: ** A serum creatinine of ≤1.5 x ULN OR ** eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:
• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :
• Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
• Platelets ≥ 50.000/mm3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding
•Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection (controlled HIV is permissible)
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
• Patient has taken one of the prohibited concomitant medications within the timeframe. ARM C: Kymriah for rRelapsed or rRefractory diffuse large B cell lymphoma
Inclusion Criteria:

• Age and Disease Status
• Adult patients (age ≥ 18 years)
• with relapsed or refractory (r/r) large B-cell lymphoma, including
• diffuse large B-cell lymphoma (DLBCL) not otherwise specified,
• high grade B-cell lymphoma
• and DLBCL arising from follicular lymphoma.
• Disease status:
• after two or more lines of systemic therapy or
• relapse after autologous HCT
• Performance Status
• ECOG performance status 0-2
• ALC >/=100/uL at screening (prior to apheresis)
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m^2
• Liver function defined as:
• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as :
• Absolute neutrophil count (ANC) > 1.000/mm3 (only for NHL)
• Platelets ≥ 50.000/mm3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided)
• Other Inclusion Criteria
• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding
•Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active or inactive HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis.
• Patient has taken one of the prohibited concomitant medications within the timeframe ARM D: Tecartus (Brexucabtagene Autoleucel) for relapsed or refractory mantle cell lymphoma
Inclusion Criteria:

• Age and Disease Status * with relapsed or refractory (r/r) mantle cell lymphoma, including
• prior anthracycline or Bendamustine containing therapy
• prior Rituximab or other CD20 directed antibody (or inability to treat with CD20 MoAb)
• not a candidate or relapse after autologous HCT
• active disease at enrollment
• Performance Status *ECOG performance status 0-1
• Organ Function
• Renal function defined as:
• A serum creatinine of ≤1.5 x ULN OR
• eGFR ≥ 50 mL/min/1.73 m2
• Liver function defined as:
• ALT ≤ 5 times the ULN for age (unless due to disease)
• Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN
• Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 > 91% on room air
• Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA
• Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as:
• Absolute neutrophil count (ANC) > 1,000/mm^3 (only for NHL)
• Platelets ≥ 50,000/mm^3 (transfusion support can be provided)
• Hemoglobin >8.0 mg/dl (transfusion support can be provided) Other
Inclusion Criteria:

• Life expectancy ≥12 weeks
• Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control.
• Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures.
Exclusion Criteria:

• Pregnant or breastfeeding
•Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy.
• Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma.
• Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis.
• Uncontrolled active hepatitis B or hepatitis C
• Active HIV infection
• Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion)
• Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion
• Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion
• Intolerance to the excipients of the CAR-T cell product
• Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped >72 hours prior to apheresis).
• Patient has taken one of the prohibited concomitant medications within the timeframe
Drug: KYMRIAH, Drug: YESCARTA, Drug: Fludarabine 30mg/m2 4 doses, Drug: Cyclophosphamide 500 mg/m2, 2 doses, Drug: Fludarabine 30mg/m2 3 doses, Drug: Cyclophosphamide 500 mg/m2, 3 doses, Drug: Fludarabine 25mg/m2 3 days, Drug: Cyclophosphamide 250 mg/m2, 3 days, Drug: Tecartus
Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
ALL, CAR-T, CAR19-T, chimeric antigen receptor T cells
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Tamy Grainger, RN - (tgraing1@fairview.org)

T Cell Receptor α/β TCD HCT in Patients With Fanconi Anemia

The primary objective is to determine the incidence of grade II-IV acute graft versus host disease (GVHD) by Day 100 using an alpha/beta T cell depleted peripheral blood stem cells (PBSC) and without routine GVHD prophylaxis.

Margaret MacMillan, MD
macmi002@umn.edu
All
up to 65 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03579875
STUDY00003182
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Patient Selection:
Inclusion Criteria:

• Diagnosis of Fanconi anemia
• Less than 65 years of age
• Karnofsky performance status of ≥ 70% or, for children < 16 years of age, Lansky Play Score ≥ 50
• Presence of at least one of the following risk factors:
• Severe aplastic anemia (SAA) defined as: Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions:
• platelet count <20 x 109/L
• absolute neutrophil count of <5 x 108/L
• hemoglobin <8 g/dL
• Myelodysplastic syndrome (MDS) or acute leukemia
• High risk genotype
• Adequate organ function defined as:
• Bilirubin, AST or ALT, ALP <5 x normal, Cardiac: left ventricle ejection fraction (LEFV) ≥45% by ECHO
• Pulmonary: DLCO, FEV1, FVC ≥ 40% predicted, and absence of O2 requirements. For children that are not able to cooperate with PFTs, a pulse oximetry with exercise should be attempted. If neither test can be obtained it should be clearly stated in the physician's note.
• Identification of a suitable donor for peripheral blood cells per match criteria found in Section 5.
• Females of childbearing potential and males with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• Able to provide written voluntary consent prior to the performance of any research related tests or procedures with parental/guardian consent for minor (and assent as appropriate)
Exclusion Criteria:

• Pregnant or breastfeeding as the treatment used in this study are Pregnancy Category D. Females of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days of study registration
• Active, uncontrolled infection within 1 week prior to starting study therapy
• Malignant solid tumor cancer within previous 2 years Donor Selection (Inclusion Criteria): meets one of the following match criteria:
• an HLA-A, B, DRB1 matched sibling donor (matched sibling)
• an HLA-A, B, DRB1 matched related donor (other than sibling)
• a related donor mismatched at 1 HLA-A, B, C and DRB1 antigen
• 7-8/8 HLA-A,B,C,DRB1 allele matched unrelated donor per current institutional guidelines Patients and donors are typed for HLA-A and B using serological or molecular techniques and for DRB1 using high resolution molecular typing. If a donor has been selected on the basis of HLA-A, B, C and DRB1 typing as above, preference will be made for donors matched at the HLA-C locus.
• Body weight of at least 40 kilograms and at least 12 years of age
• Willing and able to undergo mobilized peripheral blood apheresis
• In general good health as determined by the medical provider
• Adequate organ function defined as:
• Hematologic: hemoglobin, WBC, platelet within 10% of upper and lower limit of normal range of test (gender based for hemoglobin)
• Hepatic: ALT < 2 x upper limit of normal
• Renal: serum creatinine < 1.8 mg/dl
• Performance of a donor infectious disease screen panel including CMV Antibody, Hepatitis B Surface Antigen, Hepatitis B Core Antibody, Hepatitis C Antibody, HIV 1/2 Antibody, HTLVA 1/2 Antibody, Treponema, and Trypanosoma Cruzi (T. Cruzi) plus HBV, HCV, WNV, HIV by nucleic acid testing (NAT); and screening for evidence of and risks factors for infection with Zika virus, or per current standard institutional donor screen
•must be negative for HIV and active hepatitis B
• Not pregnant
•females of childbearing potential must have a negative pregnancy test within 7 days of mobilization start
• Voluntary written consent (parent/guardian and minor assent, if < 18 years) prior to the performance of any research related procedure
Drug: Total Body Irradiation (TBI) (Plan 1), Drug: Cyclophosphamide (CY) (Plan 1), Drug: Fludarabine (FLU), Drug: Methylprednisolone (MP), Device: Donor mobilized PBSC infusion, Drug: G-CSF, Drug: Cyclophosphamide (CY) (Plan 2), Drug: Rituximab, Drug: Busulfan
Fanconi Anemia, Severe Aplastic Anemia, Myelodysplastic Syndromes
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Masonic Cancer Center at University of Minnesota — Minneapolis, Minnesota Lisa Burke, RN - (lburke3@Fairview.org)

Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HaploHCT) Following Reduced Intensity Conditioning (RIC) for Selected High Risk Non-Malignant Diseases

The objective of this study is to establish safety as measured by sustained hematopoietic engraftment and efficacy as measured by 1 year overall survival.

Christen Ebens
ebens012@umn.edu
All
up to 25 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03367546
STUDY00001922
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Inclusion Criteria:

• Sickle Cell Disease (SCD) * If diagnosis of SCD must meet one or more of the following disease characteristics:
• Stroke, CNS hemorrhage or a neurologic event lasting longer than 24 hours, or abnormal cerebral MRI or cerebral arteriogram or MRI angiographic study and impaired neuropsychological testing
• Acute chest syndrome with a history of recurrent hospitalizations or exchange transfusions
• Recurrent vaso-occlusive pain 3 or more episodes per year for 3 years or more years or recurrent priapism,
• Impaired neuropsychological function and abnormal cerebral MRI scan
• Stage I or II sickle lung disease,
• Sickle nephropathy (moderate or severe proteinuria or a glomerular filtration rate [GFR] 30-50% of the predicted normal value)
• Bilateral proliferative retinopathy and major visual impairment in at least one eye
• Osteonecrosis of multiple joints with documented destructive changes
• Requirement for chronic transfusions
• RBC alloimmunization
• Transfusion Dependent Alpha- or Beta-Thalassemia
• Other Non-Malignant Hematologic Disorders: Transfusion dependent or involve other potential life-threatening cytopenias, including but not limited to Paroxysmal Nocturnal Hemoglobinuria, Glanzmann's Thrombasthenia, Severe Congenital Neutropenia and Shwachman-Diamond Syndrome
• cALD
• Diagnosis of ALD by abnormal plasma very long chain fatty acid (VLCFA) profile or ABCD1 gene mutation
• Cerebral disease on MRI
• Absence of a Major Functional Disability (cortical blindness, loss of communication, wheelchair dependence) on the ALD Neurologic Function Scale
• Other inherited metabolic disorders: Any other inherited metabolic disorder for which alloHCT is indicated and for whom, in the opinion of the treating physician, the patient's best treatment option is with a haploidentical donor following non-myeloablatve conditioning.
• Age, Performance Status, Consent
• Age: 0-55 years
• Performance Status: Karnofsky ≥ 70%, Lansky play score ≥ 70
• Consent: voluntary written consent (adult or parental/guardian)
• Adequate Organ Function
• Renal: Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children
• Hepatic: Bilirubin and ALT <3 times the upper limit of institutional normal
• Cardiac: Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40%.
Exclusion Criteria:

• Availability of a suitable HLA-matched related donor
• Uncontrolled infection
• Pregnant or breastfeeding
• HIV positive
Procedure: Blood and Marrow Transplant
Sickle Cell Disease, Thalassemia, High Risk Hematologic Disorders, Cerebral Adrenoleukodystrophy, Inherited Metabolic Disorders
SCD, cALD
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Masonic Caner Center at University of Minnesota — Minneapolis, Minnesota Lisa Burke - (lburke3@Fairview.org)

Auto Stem Cell Transplant for Lymphoma Patients

The primary objective is to estimate overall survival (OS) at 3 years post-transplant for patients who received the radiation free preparative regimen BEAM.

Veronika Bachanova, MD
bach0173@umn.edu
All
up to 75 Years old
Phase 2
This study is NOT accepting healthy volunteers
NCT03125642
1611M99805
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Inclusion Criteria:

• Eligible Diseases 1. Non-Hodgkin's Lymphoma (NHL)
• Patients with chemo-sensitive histologically confirmed NHL will be eligible for this treatment protocol contingent on histologic sub-classification.
• Patients in partial or complete remission following cell therapy will also be eligible.
• NHL patients with resistant or refractory lymphoma (no PR following up to three cycles of combination chemotherapy) will not be eligible for transplant in this trial.
• Lymphoblastic Lymphoma: 1. All patients will be eligible in second or greater complete remission (CR) or first or subsequent partial remission (PR) 2. Patients with any high-risk features will be eligible in first complete remission 3. High risk features include: Stage IV, LDH >2 x upper limit of normal, ≥ 2 extranodal sites
• Mature B-cell Lymphoma 1. Follicular Lymphoma and other indolent lymphoma in ≥ second CR2/PR2 2. Diffuse Large B-Cell Lymphoma: in ≥ CR2 or ≥ PR1; a high intermediate or high IPI (≥ 2 for age-adjusted IPI or ≥3 for IPI) at diagnosis and double-hit or triple-hit lymphoma will be eligible in first CR; transformed lymphoma from FL (or other indolent lymphoma) or chronic lymphocytic leukemia will be eligible if chemosensitive and bone marrow is negative 3. Mantle Cell Lymphoma: in first or greater CR or PR 4. Burkitt's/Burkitt's like: all patients except localized lymphoma will be eligible any time after initial therapy (after achievement of first complete remission), or in partial remission if they fail to achieve CR; patients with localized (stage I or Ziegler stage A) will be eligible only if they fail to achieve CR1 or after relapse
• Mature T-Cell Lymphoma 1. Chemosensitive T-cell lymphomas including Primary T-cell not otherwise specified angioimmunoblastic, and ALK-positive anaplastic large cell, will be eligible after initial therapy, whether or not CR is achieved. 2. Mycosis fungoides/Sezary syndrome will be eligible in ≥CR2/PR2 2. Hodgkin Lymphoma (HL)
• Patients with histologically proven HL will be eligible for transplantation after failing prior therapy.
• Patients with resistant disease (initial or at relapse): those who fail to achieve an objective partial response to three cycles of combination non-cross resistant chemotherapy will not be eligible for transplant in this trial.
• For stage I/II patients treated with primary chemotherapy-radiation, they must have failed (no CR or progression after CR) at least one salvage combination chemotherapy treatment regimen
• For advanced (stage III/IV) Hodgkin disease, patients must have failed an Adriamycin containing regimen (ABVD) or an alternative non-cross resistant regimen (e.g. MOPP)
• Patients with any high-risk features will also be eligible, including those who: 1. fail to achieve complete remission with initial combination chemotherapy 2. have bulky disease after initial therapy (chemotherapy or radiation) defined as residual mediastinal mass ≥ 5 cm or other residual mass ≥ 10 cm accompanied by other features of persisting disease (e.g., PET scan positive; high LDH; enlarging on serial x-rays or biopsy positive) will be eligible
•if feasible, persistent disease should be proven by biopsy
• Patients should receive chemotherapy to attempt to achieve CR or minimal disease state for all patients pre-transplantation. The use of up to three cycles of non-cross resistant combination chemotherapy is advised.
• Residual areas of limited disease should be considered for radiotherapy after and not prior to transplantation. 3. HIV positive patients who are otherwise eligible for this study may be enrolled if they meet the following requirements:
• Are seen in the infectious disease (ID)/HIV clinic prior to enrollment on study for the purpose of determining eligibility and for local coordination of HIV care during the peri-transplant period.
• Are on maximally active anti-HIV regimen to control disease as determined appropriate by the ID/HIV physicians. For the majority of patients, this will be a highly active anti-retroviral therapy (HAART)-type therapy including a protease inhibitor.
• CD4+ ≥ 50/µL
• HIV RNA viral load ≤ 100,000 copies per mL on each of samples 4 weeks apart. The most recent level must be within 30 days of enrollment.
• Performance Status: Karnofsky Performance Status ≥ 80% for patients ≥ 16 years of age or Lansky Play Score ≥ 80 for patients < 16 years of age. Note: if poor performance status is due to lymphoma
•KPS ≥ 60% or LPS ≥ 60 is acceptable
• Organ Function 1. No evidence of serious organ dysfunction that is not attributable to tumor including: 1. Hematologic:
• hemoglobin > 8 gm/dL
• WBC > 2.5 x 109/L with an ANC > 1.5 x 109/L off G-CSF or GM-CSF for 10 days or Neulasta for 21 days
• platelets > 100 x 109/L without transfusion
• bone marrow cellularity of > 20% with <5% involvement with tumor 2. Renal: GFR > 50 ml/min/1.73m2 or serum creatinine ≤ 2.5 x ULN for age 3. Hepatic: no history of severe prior or ongoing chronic liver disease. Total bilirubin ≤ 2.0 mg/dl, AST and alkaline phosphatase <5x upper limit of normal 4. Cardiac: free of symptoms of uncontrolled cardiac disease including unstable angina, decompensated congestive heart failure, or arrhythmia. The ejection fraction by gated cardiac blood flow scan (MUGA) or Echocardiogram must be >40% 5. Pulmonary: no significant obstructive airways disease (FEV1 must be ≥ 50%) and must have acceptable diffusion capacity (corrected DLCO > 50% of predicted) 6. Central Nervous System: Patients with a history of CNS involvement by lymphoma or with relapsed primary CNS lymphoma will be eligible for Cy/TBI arm. Patients with active CNS disease are eligible if they have completed a standard treatment for CNS lymphoma and have no evidence of progressive CNS disease at the time of enrollment
• Other Inclusion Criteria 1. At least 4 weeks from previous chemotherapy; 6 weeks from nitrosoureas 2. Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment 3. Patients who are carriers of Hepatitis B will be included in this study 4. Voluntary written consent
Exclusion Criteria:

• Pregnant or breastfeeding: Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
• Eligible for any higher priority transplant protocols
• Chemotherapy resistant disease
• Unrelated active infection
Drug: Etoposide, Drug: BCNU, Drug: AraC, Drug: Melphalan, Procedure: Peripheral blood stem cell transplantation, Biological: G-CSF, Drug: Cyclophosphamide, Radiation: Total Body Irradiation
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Lymphoblastic Lymphoma, Mature B-cell Lymphomas, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Burkitt's/Burkitt's like, Mature T-Cell Lymphoma
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Location Contacts
Masonic Cancer Center, University of Minnesota — Minneapolis, Minnesota Timothy Krepski - (tkrepsk1@fairview.org)