NCT02458235 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2020-10-12

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).

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Relapse Rate

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outcome · POSTED

Frequency of System Specific Grade 3 or Higher Treatment-related Adverse Events

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outcome · POSTED

Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)

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outcome · POSTED

Proportion of Participants With Serious Infection

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outcome · POSTED

Proportion of Participants With Severe Hematologic Toxicity Including Graft Failure

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outcome · POSTED

Number of Participants Whom Had >2 Dose Reductions for Any Reason

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outcome · POSTED

Median Relapse-free Survival

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outcome · POSTED

Median Time to Relapse

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: 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%
healthy Volunteers: false
maximum Age: 29 Years
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

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.
intervention Names
Drug: azacitidine
Biological: donor lymphocyte infusion
label
Azacitidine/donor lymphocyte infusion
type
EXPERIMENTAL

interventions

arm Group Labels
Azacitidine/donor lymphocyte infusion
description
40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals
name
azacitidine
other Names
Vidaza®, Ladakamycin
type
DRUG
arm Group Labels
Azacitidine/donor lymphocyte infusion
description
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.
name
donor lymphocyte infusion
type
BIOLOGICAL

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 17
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

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%.
measure
Relapse Rate
time Frame
Up to 2 years
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.
measure
Frequency of System Specific Grade 3 or Higher Treatment-related Adverse Events
time Frame
Up to 2 years
description
Proportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.
measure
Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)
time Frame
Up to 2 years
description
The proportion of participants will be reported for Grade 3-4 invasive fungal infection or disease caused by viral infections
measure
Proportion of Participants With Serious Infection
time Frame
Up to 2 years
description
The proportion of participants will be reported for Grade 4 severe hematologic toxicities including graft failure
measure
Proportion of Participants With Severe Hematologic Toxicity Including Graft Failure
time Frame
Up to 2 years
description
The number of participants whom had greater than 2 dose reductions for any reason.
measure
Number of Participants Whom Had >2 Dose Reductions for Any Reason
time Frame
Up to 2 years

secondary Outcomes

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
measure
Median Relapse-free Survival
time Frame
Up to 2 years
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.
measure
Median Time to Relapse
time Frame
Up to 2 years

Full 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).
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.

Source references

references

citation
Justin T. Wahlstrom, Biljana N. Horn, Carol Fraser-Browne, Rebecca Hoeweler, Ying Lu, Alexis Melton, Jennifer Willert, Christopher C. Dvorak; Azacitidine Administration Following Hematopoietic Stem Cell Transplantation Is Safe and Feasible in Children with Acute Leukemia. Blood 2016; 128 (22): 4805. https://doi.org/10.1182/blood.V128.22.4805.4805
type
RESULT

Source notices and limitations

Discovery and provenance

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Preserved source evidence · Not medical advice