Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

This hypothesis will be rejected if the 95% confidence interval for year DFS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.

Source null

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secondary · POSTED

Will be analyzed and reported descriptively.

Source null

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secondary · POSTED

Will be analyzed and reported descriptively.

Source null

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secondary · POSTED

CD4 and CD8 values at Day +28. Reported as mean (standard deviation).

Participants surviving to Day +28 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.

→

secondary · POSTED

CD4 and CD8 values at Day +90. Reported as mean (standard deviation).

Participants surviving to Day +90 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.

→

secondary · POSTED

The incidence and severity of graft-versus-host disease (GVHD) will be analyzed and reported descriptively. Clinical manifestations including skin rash, diarrhea, and liver function test abnormalities will be assessed. GVHD will be staged using established clinical grading systems: acute GVHD will be graded according to the modified Glucksberg criteria, and chronic GVHD will be graded using the NIH consensus criteria. These grading systems classify GVHD severity based on organ involvement and clinical symptoms. Higher stages or grades reflect more severe disease and are considered worse outcomes.

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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id: NCT01760655
trial label: Reduced-Intensity Conditioning Before Donor Stem Cell Transplant in With High-Risk 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. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0000
source section id
NCT01760655-om-0000
source outcome index
0
endpoint
Disease-free Survival (DFS)
endpoint definition
This hypothesis will be rejected if the 95% confidence interval for year DFS rate computed from the estimated Kaplan-Meier survival curves will be entirely above 0.35.
time origin
1 year post hematopoietic stem cell transplant (HSCT)
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0001
source section id
NCT01760655-om-0001
source outcome index
1
endpoint
Overall Survival
endpoint definition
Will be analyzed and reported descriptively.
time origin
1 year post HSCT
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0002
source section id
NCT01760655-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Will be analyzed and reported descriptively.
time origin
3 years post HSCT
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0003
source section id
NCT01760655-om-0003
source outcome index
3
endpoint
Immune Reconstitution at Day +28
endpoint definition
CD4 and CD8 values at Day +28. Reported as mean (standard deviation).
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants surviving to Day +28 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0004
source section id
NCT01760655-om-0004
source outcome index
4
endpoint
Immune Reconstitution at Day +90
endpoint definition
CD4 and CD8 values at Day +90. Reported as mean (standard deviation).
time origin
Up to 1 year
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Participants surviving to Day +90 with evaluable data. This excludes the one subject who was a graft failure and anyone who died before 28 days.
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0005
source section id
NCT01760655-om-0005
source outcome index
5
endpoint
Incidence and Degree of Graft Versus Host Disease
endpoint definition
The incidence and severity of graft-versus-host disease (GVHD) will be analyzed and reported descriptively. Clinical manifestations including skin rash, diarrhea, and liver function test abnormalities will be assessed. GVHD will be staged using established clinical grading systems: acute GVHD will be graded according to the modified Glucksberg criteria, and chronic GVHD will be graded using the NIH consensus criteria. These grading systems classify GVHD severity based on organ involvement and clinical symptoms. Higher stages or grades reflect more severe disease and are considered worse outcomes.
time origin
Up to 1 year
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-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0000
arm key
OG000
arm label
Treatment (RIC and allogeneic PBSCT)
regimen
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01760655-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0001
arm key
OG000
arm label
Treatment (RIC and allogeneic PBSCT)
regimen
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01760655-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0002
arm key
OG000
arm label
Treatment (RIC and allogeneic PBSCT)
regimen
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01760655-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0003
arm key
OG000
arm label
Treatment (RIC and allogeneic PBSCT)
regimen
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
analyzed count
56
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01760655-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0004
arm key
OG000
arm label
Treatment (RIC and allogeneic PBSCT)
regimen
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
analyzed count
44
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01760655-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
outcome key
om-0005
arm key
OG000
arm label
Treatment (RIC and allogeneic PBSCT)
regimen
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV on days -15 to -12, busulfan IV on days -14 to -13, DLI on day -6, and cyclophosphamide IV on days -3 and -2. Patients also undergo TBI on day -10. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV on days -1 to 42 followed by taper and mycophenolate mofetil IV BID on days -1 to 28 Fludarabine phosphate: Given IV Busulfan: Given IV Total-Body Irradiation: Undergo TBI Therapeutic Allogeneic Lymphocytes: Undergo DLI Cyclophosphamide: Given IV Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSCT Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT Tacrolimus: Given IV Mycophenolate Mofetil: Given IV Laboratory Biomarker Analysis: Correlative studies
analyzed count
59
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01760655-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-myeloid-leukemia-with-inv-3-q21-3-q26-2-gata2-mecom
nct id
NCT01760655
harm key
EG000
source section id
NCT01760655-ae
event group key
EG000
event group label
Treatment (RIC and allogeneic PBSCT)
serious affected
30
serious at risk
62
other affected
43
other at risk
62
frequency threshold
0
collection period
All patients will be followed for adverse experiences (AEs) (serious and nonserious), regardless of relationships to study treatment, from the time of enrollment until d +100 after transplant
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