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
Enrollment
1
Location
1
Arm
45.4
Actual Duration (Months)
0.4
Patients Per Site Per Month

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 DiseaseIntervention/TreatmentPhase
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

ArmIntervention/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

    SiteCityStateCountryPostal Code
    1University of California San FranciscoSan FranciscoCaliforniaUnited States94143

    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 TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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
    STARTED17
    COMPLETED17
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    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
    TitleRelapse Rate
    DescriptionRelapse 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 FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Number [percentage of participants]
    23.5
    138.2%
    2. Primary Outcome
    TitleFrequency of System Specific Grade 3 or Higher Treatment-related Adverse Events
    DescriptionFrequency 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 FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Count of Participants [Participants]
    0
    0%
    3. Primary Outcome
    TitleProportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)
    DescriptionProportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.
    Time FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Acute GVHD
    0.176
    1%
    Moderate to severe chronic GVHD
    0.411
    2.4%
    4. Primary Outcome
    TitleProportion of Participants With Serious Infection
    DescriptionThe proportion of participants will be reported for Grade 3-4 invasive fungal infection or disease caused by viral infections
    Time FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Number [proportion of participants]
    0.41
    2.4%
    5. Primary Outcome
    TitleProportion of Participants With Severe Hematologic Toxicity Including Graft Failure
    DescriptionThe proportion of participants will be reported for Grade 4 severe hematologic toxicities including graft failure
    Time FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    No participants experienced a severe hematologic toxicity including graft failure
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Number [proportion of participants]
    0.00
    0%
    6. Primary Outcome
    TitleNumber of Participants Whom Had >2 Dose Reductions for Any Reason
    DescriptionThe number of participants whom had greater than 2 dose reductions for any reason.
    Time FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Number [participants]
    0
    0%
    7. Secondary Outcome
    TitleMedian Relapse-free Survival
    DescriptionRelease-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 FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Median (Full Range) [months]
    22
    8. Secondary Outcome
    TitleMedian Time to Relapse
    DescriptionTime 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 FrameUp to 2 years

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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 Participants17
    Median (Full Range) [months]
    3

    Adverse Events

    Time FrameUp to 2 years
    Adverse Event Reporting Description
    Arm/Group TitleAzacitidine/Donor Lymphocyte Infusion
    Arm/Group DescriptionPatients 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
    Total0/17 (0%)
    Serious Adverse Events
    Azacitidine/Donor Lymphocyte Infusion
    Affected / at Risk (%)# Events
    Total10/17 (58.8%)
    Cardiac disorders
    Cardiac disorders - Other1/17 (5.9%) 1
    Gastrointestinal disorders
    Diarrhea1/17 (5.9%) 1
    General disorders
    Fever1/17 (5.9%) 1
    Edema face1/17 (5.9%) 1
    Hepatobiliary disorders
    Hepatobiliary disorders - Other1/17 (5.9%) 1
    Immune system disorders
    Immune system disorders - Other3/17 (17.6%) 3
    Infections and infestations
    Infections and infestations - Other1/17 (5.9%) 1
    Investigations
    Platelet count decreased1/17 (5.9%) 1
    Elevated transaminases1/17 (5.9%) 1
    Musculoskeletal and connective tissue disorders
    Musculoskeletal and connective tissue disorder - Other1/17 (5.9%) 1
    Skin and subcutaneous tissue disorders
    Rash maculo-papular1/17 (5.9%) 1
    Other (Not Including Serious) Adverse Events
    Azacitidine/Donor Lymphocyte Infusion
    Affected / at Risk (%)# Events
    Total17/17 (100%)
    Blood and lymphatic system disorders
    Neutropenia1/17 (5.9%) 1
    Pancytopenia2/17 (11.8%) 2
    Thrombocytopenia1/17 (5.9%) 1
    Ear and labyrinth disorders
    Conductive Hearing Loss1/17 (5.9%) 1
    Endocrine disorders
    Adrenal insufficiency3/17 (17.6%) 3
    Eye disorders
    Anisocoria1/17 (5.9%) 1
    Gastrointestinal disorders
    Constipation2/17 (11.8%) 2
    Hemorrhoids1/17 (5.9%) 1
    Nausea3/17 (17.6%) 3
    Vomiting3/17 (17.6%) 3
    General disorders
    Chest pain1/17 (5.9%) 1
    Chronic Pain3/17 (17.6%) 3
    Fever4/17 (23.5%) 4
    Hepatobiliary disorders
    Cholestatic liver disease1/17 (5.9%) 1
    Cholecystitis1/17 (5.9%) 1
    Infections and infestations
    Bacteremia1/17 (5.9%) 1
    Cytomegalovirus (CMV) viremia2/17 (11.8%) 2
    Human Herpesvirus 6 (HHV-6) viremia1/17 (5.9%) 1
    Human Metapneumovirus (hMPV)1/17 (5.9%) 1
    Pulmonary aspergillosis1/17 (5.9%) 1
    Injury, poisoning and procedural complications
    Fracture1/17 (5.9%) 1
    Investigations
    Acute GVHD3/17 (17.6%) 3
    Chronic GVHD7/17 (41.2%) 7
    Electrolyte Abnormality1/17 (5.9%) 1
    Post Transplant Immunodeficiency17/17 (100%) 17
    Weight Loss2/17 (11.8%) 2
    Abnormal alanine aminotransferase (ALT) and aspartate aminotransferase (AST)1/17 (5.9%) 1
    Metabolism and nutrition disorders
    Hypomagnesemia1/17 (5.9%) 1
    Iron overload4/17 (23.5%) 4
    Malnutrition1/17 (5.9%) 1
    Musculoskeletal and connective tissue disorders
    Avascular necrosis1/17 (5.9%) 1
    Osteopenia1/17 (5.9%) 1
    Nervous system disorders
    Epileptic seizures1/17 (5.9%) 1
    Headaches1/17 (5.9%) 1
    Pseudoseizures1/17 (5.9%) 1
    Psychiatric disorders
    Anxiety1/17 (5.9%) 1
    Depression1/17 (5.9%) 1
    Emotional disturbance1/17 (5.9%) 1
    Reproductive system and breast disorders
    Foreskin adhesions1/17 (5.9%) 1
    Respiratory, thoracic and mediastinal disorders
    Pleural effusion1/17 (5.9%) 1
    Skin and subcutaneous tissue disorders
    Rash1/17 (5.9%) 1
    Vascular disorders
    Hypertension1/17 (5.9%) 1
    Neuropathy1/17 (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/TitleDr. Christopher Dvorak, MD
    OrganizationUniversity of California, San Francisco
    Phone(415) 476-0554
    EmailChristopher.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