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)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 45.4
• Patients Per Site Per Month: 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
Acute Myelogenous Leukemia; Acute Lymphoid Leukemia; Juvenile Myelomonocytic Leukemia; Myelodysplastic Syndrome	Drug: azacitidine; Biological: donor lymphocyte infusion	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)

• Informed Consent Form - May 5, 2015
• Study Protocol and Statistical Analysis Plan - Nov 17, 2016

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: pediatric leukemia myelodysplastic syndrome azacitidine
• Additional relevant MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Hematologic Neoplasms; Leukemia, Myeloid, Acute; Leukemia, Lymphoid; Leukemia, Myelomonocytic, Juvenile; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Azacitidine

Study Results

Participant Flow

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
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.