Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation

Sponsor
University of California, San Francisco (Other)
Overall Status
Completed
CT.gov ID
NCT02458235
Collaborator
Hellman Foundation (Other)
17
1
1
45.4
0.4

Study Details

Study Description

Brief Summary

The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (HSCT).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

This is a phase II single-arm trial of azacitidine (IV or SC) in combination with escalating donor lymphocyte infusion (DLI). Patients will be enrolled on the study by day +28 +/- 7 post-transplant, prior to withdrawal of immunosuppression or administration of donor lymphocyte infusion (DLI). They will have donor chimerism and minimal residual disease (MRD) testing from peripheral blood (PB) and bone marrow (BM) on day +28 ┬▒ 7. Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative MRD results. Depending on risk assessment, immunosuppression will be tapered according to standard or fast schedules, and patients (with the exception of low-risk ALL patients) will receive one cycle of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days). After tapering immunosuppression, chimerism will be repeated and patients will receive up to 6 additional cycles of low-dose azacitidine, depending on risk assessment. For patients who meet criteria for high risk of relapse, azacitidine will be combined with escalating doses of DLI for a maximum of 7 cycles in total. Risk and safety assessments, including routine laboratory parameters, donor chimerism, minimal residual disease, and GHVD activity will be assessed following each cycle. Chimerism and minimal residual disease testing will be repeated every cycle by peripheral blood (PB), and bone marrow (BM) will be tested every other cycle. Patients will be followed by laboratory monitoring and physician evaluation prior to each cycle, and will be followed for two years post-transplant to study toxicity and GVHD outcomes.

Study Design

Study Type:
Interventional
Actual Enrollment :
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Risk-adapted Donor Lymphocyte Infusion and Azacitidine for the Prevention of Hematologic Malignancy Relapse Following Allogeneic Stem Cell Transplantation
Actual Study Start Date :
Jun 2, 2015
Actual Primary Completion Date :
Mar 15, 2019
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Azacitidine/donor lymphocyte infusion

Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI.

Drug: azacitidine
40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals
Other Names:
  • Vidaza┬«, Ladakamycin
  • Biological: donor lymphocyte infusion
    For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.

    Outcome Measures

    Primary Outcome Measures

    1. Relapse Rate [Up to 2 years]

      Relapse rate will be estimated using a percentage of participants who relapsed. It is assumed that the rate of relapse in pediatric acute leukemia post-transplant would be 40%, azacitidine +/- Donor Lymphocyte Infusion (DLI) would reduce the 2-year relapse rate by approximately 40% to a rate of 25%.

    2. Frequency of System Specific Grade 3 or Higher Treatment-related Adverse Events [Up to 2 years]

      Frequency of system specific adverse events of interest include renal, hepatic, cardiac, pulmonary, or neurologic toxicities. Toxicities will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

    3. Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD) [Up to 2 years]

      Proportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.

    4. Proportion of Participants With Serious Infection [Up to 2 years]

      The proportion of participants will be reported for Grade 3-4 invasive fungal infection or disease caused by viral infections

    5. Proportion of Participants With Severe Hematologic Toxicity Including Graft Failure [Up to 2 years]

      The proportion of participants will be reported for Grade 4 severe hematologic toxicities including graft failure

    6. Number of Participants Whom Had >2 Dose Reductions for Any Reason [Up to 2 years]

      The number of participants whom had greater than 2 dose reductions for any reason.

    Secondary Outcome Measures

    1. Median Relapse-free Survival [Up to 2 years]

      Release-free survival rate is defined as the median length of time after beginning treatment that the participant survives without progression or relapse, reported in months

    2. Median Time to Relapse [Up to 2 years]

      Time to relapse is defined as the length of time after beginning treatment until the participant has experienced a relapse in disease, measured in months.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 29 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients age 0 - 29.9 years undergoing allogeneic peripheral blood stem cell transplant

    • Patients with acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL)

    • Patients with juvenile myelomonocytic leukemia (JMML)

    • Patients with myelodysplastic syndrome (MDS)

    Exclusion Criteria:
    • Patients who have had a prior transplant.

    • Patients with Fanconi anemia or other cancer-predisposition syndromes

    • Patients with expected survival <12 weeks

    • Lansky score <60%

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco
    • Hellman Foundation

    Investigators

    • Principal Investigator: Christopher C Dvorak, M.D., University of California, San Francisco

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT02458235
    Other Study ID Numbers:
    • 140813
    • NCI-2015-02240
    First Posted:
    Jun 1, 2015
    Last Update Posted:
    Oct 12, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of California, San Francisco
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Period Title: Overall Study
    STARTED 17
    COMPLETED 17
    NOT COMPLETED 0

    Baseline Characteristics

    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Overall Participants 17
    Age, Customized (Count of Participants)
    0-9 years
    7
    41.2%
    10-19 years
    9
    52.9%
    20-29 years
    1
    5.9%
    Sex: Female, Male (Count of Participants)
    Female
    3
    17.6%
    Male
    14
    82.4%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    3
    17.6%
    Not Hispanic or Latino
    9
    52.9%
    Unknown or Not Reported
    5
    29.4%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    Asian
    3
    17.6%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    Black or African American
    1
    5.9%
    White
    5
    29.4%
    More than one race
    0
    0%
    Unknown or Not Reported
    8
    47.1%
    Region of Enrollment (participants) [Number]
    United States
    17
    100%

    Outcome Measures

    1. Primary Outcome
    Title Relapse Rate
    Description Relapse rate will be estimated using a percentage of participants who relapsed. It is assumed that the rate of relapse in pediatric acute leukemia post-transplant would be 40%, azacitidine +/- Donor Lymphocyte Infusion (DLI) would reduce the 2-year relapse rate by approximately 40% to a rate of 25%.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Number [percentage of participants]
    23.5
    138.2%
    2. Primary Outcome
    Title Frequency of System Specific Grade 3 or Higher Treatment-related Adverse Events
    Description Frequency of system specific adverse events of interest include renal, hepatic, cardiac, pulmonary, or neurologic toxicities. Toxicities will be graded using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Count of Participants [Participants]
    0
    0%
    3. Primary Outcome
    Title Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)
    Description Proportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Acute GVHD
    0.176
    1%
    Moderate to severe chronic GVHD
    0.411
    2.4%
    4. Primary Outcome
    Title Proportion of Participants With Serious Infection
    Description The proportion of participants will be reported for Grade 3-4 invasive fungal infection or disease caused by viral infections
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Number [proportion of participants]
    0.41
    2.4%
    5. Primary Outcome
    Title Proportion of Participants With Severe Hematologic Toxicity Including Graft Failure
    Description The proportion of participants will be reported for Grade 4 severe hematologic toxicities including graft failure
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    No participants experienced a severe hematologic toxicity including graft failure
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Number [proportion of participants]
    0.00
    0%
    6. Primary Outcome
    Title Number of Participants Whom Had >2 Dose Reductions for Any Reason
    Description The number of participants whom had greater than 2 dose reductions for any reason.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Number [participants]
    0
    0%
    7. Secondary Outcome
    Title Median Relapse-free Survival
    Description Release-free survival rate is defined as the median length of time after beginning treatment that the participant survives without progression or relapse, reported in months
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Median (Full Range) [months]
    22
    8. Secondary Outcome
    Title Median Time to Relapse
    Description Time to relapse is defined as the length of time after beginning treatment until the participant has experienced a relapse in disease, measured in months.
    Time Frame Up to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    Measure Participants 17
    Median (Full Range) [months]
    3

    Adverse Events

    Time Frame Up to 2 years
    Adverse Event Reporting Description
    Arm/Group Title Azacitidine/Donor Lymphocyte Infusion
    Arm/Group Description Patients will be stratified according to risk categories (low, standard and high), defined by GVHD status, mixed versus full donor chimerism, and positive versus negative Minimal Residual Disease (MRD) results. Patients will receive up to 7 cycles of low-dose azacitidine (40mg/m2 IV/SC daily x 4 days) at 6 weekly intervals, except for low risk ALL patients who may not receive treatment after withdrawal of immunosuppression. Standard risk patients will receive an additional 6 cycles of azacitidine alone. High risk patients will receive an additional 6 cycles of azacitidine plus escalating DLI. azacitidine: 40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals donor lymphocyte infusion: For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
    All Cause Mortality
    Azacitidine/Donor Lymphocyte Infusion
    Affected / at Risk (%) # Events
    Total 0/17 (0%)
    Serious Adverse Events
    Azacitidine/Donor Lymphocyte Infusion
    Affected / at Risk (%) # Events
    Total 10/17 (58.8%)
    Cardiac disorders
    Cardiac disorders - Other 1/17 (5.9%) 1
    Gastrointestinal disorders
    Diarrhea 1/17 (5.9%) 1
    General disorders
    Fever 1/17 (5.9%) 1
    Edema face 1/17 (5.9%) 1
    Hepatobiliary disorders
    Hepatobiliary disorders - Other 1/17 (5.9%) 1
    Immune system disorders
    Immune system disorders - Other 3/17 (17.6%) 3
    Infections and infestations
    Infections and infestations - Other 1/17 (5.9%) 1
    Investigations
    Platelet count decreased 1/17 (5.9%) 1
    Elevated transaminases 1/17 (5.9%) 1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorder - Other 1/17 (5.9%) 1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 1/17 (5.9%) 1
    Other (Not Including Serious) Adverse Events
    Azacitidine/Donor Lymphocyte Infusion
    Affected / at Risk (%) # Events
    Total 17/17 (100%)
    Blood and lymphatic system disorders
    Neutropenia 1/17 (5.9%) 1
    Pancytopenia 2/17 (11.8%) 2
    Thrombocytopenia 1/17 (5.9%) 1
    Ear and labyrinth disorders
    Conductive Hearing Loss 1/17 (5.9%) 1
    Endocrine disorders
    Adrenal insufficiency 3/17 (17.6%) 3
    Eye disorders
    Anisocoria 1/17 (5.9%) 1
    Gastrointestinal disorders
    Constipation 2/17 (11.8%) 2
    Hemorrhoids 1/17 (5.9%) 1
    Nausea 3/17 (17.6%) 3
    Vomiting 3/17 (17.6%) 3
    General disorders
    Chest pain 1/17 (5.9%) 1
    Chronic Pain 3/17 (17.6%) 3
    Fever 4/17 (23.5%) 4
    Hepatobiliary disorders
    Cholestatic liver disease 1/17 (5.9%) 1
    Cholecystitis 1/17 (5.9%) 1
    Infections and infestations
    Bacteremia 1/17 (5.9%) 1
    Cytomegalovirus (CMV) viremia 2/17 (11.8%) 2
    Human Herpesvirus 6 (HHV-6) viremia 1/17 (5.9%) 1
    Human Metapneumovirus (hMPV) 1/17 (5.9%) 1
    Pulmonary aspergillosis 1/17 (5.9%) 1
    Injury, poisoning and procedural complications
    Fracture 1/17 (5.9%) 1
    Investigations
    Acute GVHD 3/17 (17.6%) 3
    Chronic GVHD 7/17 (41.2%) 7
    Electrolyte Abnormality 1/17 (5.9%) 1
    Post Transplant Immunodeficiency 17/17 (100%) 17
    Weight Loss 2/17 (11.8%) 2
    Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 1/17 (5.9%) 1
    Metabolism and nutrition disorders
    Hypomagnesemia 1/17 (5.9%) 1
    Iron overload 4/17 (23.5%) 4
    Malnutrition 1/17 (5.9%) 1
    Musculoskeletal and connective tissue disorders
    Avascular necrosis 1/17 (5.9%) 1
    Osteopenia 1/17 (5.9%) 1
    Nervous system disorders
    Epileptic seizures 1/17 (5.9%) 1
    Headaches 1/17 (5.9%) 1
    Pseudoseizures 1/17 (5.9%) 1
    Psychiatric disorders
    Anxiety 1/17 (5.9%) 1
    Depression 1/17 (5.9%) 1
    Emotional disturbance 1/17 (5.9%) 1
    Reproductive system and breast disorders
    Foreskin adhesions 1/17 (5.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion 1/17 (5.9%) 1
    Skin and subcutaneous tissue disorders
    Rash 1/17 (5.9%) 1
    Vascular disorders
    Hypertension 1/17 (5.9%) 1
    Neuropathy 1/17 (5.9%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Christopher Dvorak, MD
    Organization University of California, San Francisco
    Phone (415) 476-0554
    Email Christopher.Dvorak@ucsf.edu
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT02458235
    Other Study ID Numbers:
    • 140813
    • NCI-2015-02240
    First Posted:
    Jun 1, 2015
    Last Update Posted:
    Oct 12, 2020
    Last Verified:
    Oct 1, 2020