NCT01036009 · STUDY IN CONTEXT

A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies

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.

post-hoc · POSTED

The number of patients who relapsed after 2-year primary endpoint. To assess a potential for late relapse-rate in the intervention arm only, patients in the intervention arm were provided additional follow-up until 3-yrs post transplant. The criterion for relapse was \>5% blasts in bone marrow.

surviving patients in the intervention arm who had not relapsed as of 24 months were followed for an additional 12 months (until 3 years post-transplant)

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post-hoc · POSTED

Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as \>5% blasts in bone marrow

intervention patients who relapsed after the 2 year primary study endpoint

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primary · POSTED

Definition of relapse was \>5 % blasts in bone marrow

Source null

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secondary · POSTED

2 Years Post-transplant Survival.

Source null

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secondary · POSTED

Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8. In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea.

Source null

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secondary · POSTED

Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955. The diagnosis of chronic GVHD requires the following: 1\) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses. Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores.

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: NCT01036009
trial label: A Study of Withdrawal of Immunosuppression and Donor Lymphocyte Infusions Following Allogeneic Transplant for Pediatric Hematologic Malignancies
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: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0004
source section id
NCT01036009-om-0004
source outcome index
4
endpoint
Late Relapses
endpoint definition
The number of patients who relapsed after 2-year primary endpoint. To assess a potential for late relapse-rate in the intervention arm only, patients in the intervention arm were provided additional follow-up until 3-yrs post transplant. The criterion for relapse was \>5% blasts in bone marrow.
time origin
24-36 months post-transplant
analysis role
post-hoc
reporting status
POSTED
data cutoff
Source null
population note
surviving patients in the intervention arm who had not relapsed as of 24 months were followed for an additional 12 months (until 3 years post-transplant)
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
NCT01036009
outcome key
om-0005
source section id
NCT01036009-om-0005
source outcome index
5
endpoint
Time Until Late Relapse
endpoint definition
Number of months post-transplant until late relapse, in intervention patients relapsing after the 2-year primary study endpoint. Relapse defined as \>5% blasts in bone marrow
time origin
24-36 months post-transplant
analysis role
post-hoc
reporting status
POSTED
data cutoff
Source null
population note
intervention patients who relapsed after the 2 year primary study endpoint
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
NCT01036009
outcome key
om-0000
source section id
NCT01036009-om-0000
source outcome index
0
endpoint
Relapse at 2 Years Post-transplant.
endpoint definition
Definition of relapse was \>5 % blasts in bone marrow
time origin
2 years post transplant.
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
NCT01036009
outcome key
om-0001
source section id
NCT01036009-om-0001
source outcome index
1
endpoint
2 Years Post-transplant Survival.
endpoint definition
2 Years Post-transplant Survival.
time origin
2 years post transplant
analysis role
secondary
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
NCT01036009
outcome key
om-0002
source section id
NCT01036009-om-0002
source outcome index
2
endpoint
The Incidence of Acute Graft Versus Host Disease (aGVHD).
endpoint definition
Definition and diagnostic criteria of aGVHD according to: 1994 Consensus Conference on Acute GVHD Grading. Przepiorka D1, Weisdorf D, Martin P, Klingemann HG, Beatty P, Hows J, Thomas ED. Bone Marrow Transplant. 1995 Jun;15(6):825-8. In this system, patients are divided into one of four grades (I-IV) depending on the degree, or stage, of involvement in three organs. The skin is staged with percent body surface involved, the liver is staged with degree of bilirubin elevation, and the gastrointestinal tract is staged with amount of diarrhea.
time origin
2 years post transplant
analysis role
secondary
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
NCT01036009
outcome key
om-0003
source section id
NCT01036009-om-0003
source outcome index
3
endpoint
The Incidence of Chronic GVHD (cGVHD).
endpoint definition
Diagnostic criteria of cGVHD from: Filipovich AH, Weisdorf D, Pavletic S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-host disease: I Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation 2005;11:945-955. The diagnosis of chronic GVHD requires the following: 1\) Distinction from acute GVHD; 2) Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests; 3) Exclusion of other possible diagnoses. Scoring of organ manifestations requires careful assessment of signs, symptoms, laboratory values, and other study results. A clinical scoring system (0-3) is used for evaluation of the involvement of individual organs and sites. Global assessment of severity (mild, moderate, or severe) is derived by combining organ- and site-specific scores.
time origin
2 years post transplant
analysis role
secondary
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
NCT01036009
outcome key
om-0000
arm key
OG000
arm label
Group I: Observation
regimen
Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0000
arm key
OG001
arm label
Group II: Intervention
regimen
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0001
arm key
OG000
arm label
Group I: Observation
regimen
Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0001
arm key
OG001
arm label
Group II: Intervention
regimen
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0002
arm key
OG000
arm label
Group I: Observation
regimen
Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0002
arm key
OG001
arm label
Group II: Intervention
regimen
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0003
arm key
OG000
arm label
Group I: Observation
regimen
Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0003
arm key
OG001
arm label
Group II: Intervention
regimen
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
analyzed count
26
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0004
arm key
OG000
arm label
Group II: Intervention
regimen
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
analyzed count
21
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
outcome key
om-0005
arm key
OG000
arm label
Group II: Intervention
regimen
Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I. Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01036009-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-juvenile-myelomonocytic-leukemia
nct id
NCT01036009
harm key
EG000
source section id
NCT01036009-ae
event group key
EG000
event group label
Group I: Observation
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
5
collection period
2 years
event definition
Due to the severity of illness in this patient population, this study collected and reported Adverse Events only if at least possibly related to study participation, and only in patients undergoing study intervention (intervention arm).
undenominated 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
NCT01036009
harm key
EG001
source section id
NCT01036009-ae
event group key
EG001
event group label
Group II: Intervention
serious affected
1
serious at risk
26
other affected
9
other at risk
26
frequency threshold
5
collection period
2 years
event definition
Due to the severity of illness in this patient population, this study collected and reported Adverse Events only if at least possibly related to study participation, and only in patients undergoing study intervention (intervention arm).
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