NCT02458235 · STUDY IN CONTEXT

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

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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%.

Source null

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primary · POSTED

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.

Source null

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primary · POSTED

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

Source null

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primary · POSTED

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

Source null

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primary · POSTED

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

No participants experienced a severe hematologic toxicity including graft failure

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primary · POSTED

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

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-juvenile-myelomonocytic-leukemia
nct id: NCT02458235
trial label: Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0000
source section id
NCT02458235-om-0000
source outcome index
0
endpoint
Relapse Rate
endpoint definition
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 origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0001
source section id
NCT02458235-om-0001
source outcome index
1
endpoint
Frequency of System Specific Grade 3 or Higher Treatment-related Adverse Events
endpoint definition
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 origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0002
source section id
NCT02458235-om-0002
source outcome index
2
endpoint
Proportion of Participants With Acute and Chronic Graft Versus Host Disease (GVHD)
endpoint definition
Proportion of participants with Grade 3-4 acute GVHD and moderate to severe chronic GVHD will be reported.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0003
source section id
NCT02458235-om-0003
source outcome index
3
endpoint
Proportion of Participants With Serious Infection
endpoint definition
The proportion of participants will be reported for Grade 3-4 invasive fungal infection or disease caused by viral infections
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0004
source section id
NCT02458235-om-0004
source outcome index
4
endpoint
Proportion of Participants With Severe Hematologic Toxicity Including Graft Failure
endpoint definition
The proportion of participants will be reported for Grade 4 severe hematologic toxicities including graft failure
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No participants experienced a severe hematologic toxicity including graft failure
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0005
source section id
NCT02458235-om-0005
source outcome index
5
endpoint
Number of Participants Whom Had >2 Dose Reductions for Any Reason
endpoint definition
The number of participants whom had greater than 2 dose reductions for any reason.
time origin
Up to 2 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0000
arm key
OG000
arm label
Azacitidine/Donor Lymphocyte Infusion
regimen
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.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02458235-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0001
arm key
OG000
arm label
Azacitidine/Donor Lymphocyte Infusion
regimen
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.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02458235-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0002
arm key
OG000
arm label
Azacitidine/Donor Lymphocyte Infusion
regimen
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.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02458235-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0003
arm key
OG000
arm label
Azacitidine/Donor Lymphocyte Infusion
regimen
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.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02458235-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0004
arm key
OG000
arm label
Azacitidine/Donor Lymphocyte Infusion
regimen
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.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02458235-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
outcome key
om-0005
arm key
OG000
arm label
Azacitidine/Donor Lymphocyte Infusion
regimen
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.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02458235-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT02458235
harm key
EG000
source section id
NCT02458235-ae
event group key
EG000
event group label
Azacitidine/Donor Lymphocyte Infusion
serious affected
10
serious at risk
17
other affected
17
other at risk
17
frequency threshold
5
collection period
Up to 2 years
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice