NCT01028716 · STUDY IN CONTEXT

Donor Peripheral Blood Stem Cell Transplant in Treating Patients With 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

Cumulative incidence of death without evidence of disease progression at 1 year

Source null

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primary · POSTED

Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.

Patients who were alive greater than day 100 were included

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primary · POSTED

Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.

Source null

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primary · POSTED

Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy.

Source null

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secondary · POSTED

Achievement of an absolute neutrophil count greater or equal to 500/mm\^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.

Source null

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secondary · POSTED

The first day of a sustained platelet count \> 20,000/mm\^3 with no platelet transfusions in the preceding seven days.

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-undifferentiated-leukemia
nct id: NCT01028716
trial label: Donor Peripheral Blood Stem Cell Transplant in Treating Patients With 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-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0000
source section id
NCT01028716-om-0000
source outcome index
0
endpoint
Non-relapse Mortality at 1 Year
endpoint definition
Cumulative incidence of death without evidence of disease progression at 1 year
time origin
Up to 1 year
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-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0001
source section id
NCT01028716-om-0001
source outcome index
1
endpoint
Percentage of Participants With Chronic Graft Versus Host Disease
endpoint definition
Scored according to the National Cancer Institute criteria. Mild-to-severe chronic GVHD at 2 years.
time origin
Up to 2 years post-transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Patients who were alive greater than day 100 were included
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-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0002
source section id
NCT01028716-om-0002
source outcome index
2
endpoint
Incidence of Grades III/IV Acute Graft Versus Host Disease
endpoint definition
Grading determined by organ system stages. Grade III/IV acute graft versus host disease is defined as skin: stage IV, liver: stages II-IV, and/or gastrointestinal tract: stages II-IV.
time origin
At day 84
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-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0003
source section id
NCT01028716-om-0003
source outcome index
3
endpoint
Relapse of Malignancy After Transplantation
endpoint definition
Defined by either morphological or cytogenetic evidence of acute leukemia consistent with pre-transplant features, or radiologic evidence of lymphoma progression. When in doubt, the diagnosis of recurrent or progressive lymphoma should be documented by tissue biopsy.
time origin
Up to 7 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-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0004
source section id
NCT01028716-om-0004
source outcome index
4
endpoint
Time to Neutrophil Recovery
endpoint definition
Achievement of an absolute neutrophil count greater or equal to 500/mm\^3 for three consecutive measurements on different days. The first of the three days will be designated the day of neutrophil recovery.
time origin
Up to day 84 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-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0005
source section id
NCT01028716-om-0005
source outcome index
5
endpoint
Time to Platelet Recovery
endpoint definition
The first day of a sustained platelet count \> 20,000/mm\^3 with no platelet transfusions in the preceding seven days.
time origin
Up to day 84 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-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0000
arm key
OG000
arm label
Treatment (Nonmyeloablative HCT, TBI)
regimen
Patients receive fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Patients undergo donor peripheral blood stem cell transplant on day 0. Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01028716-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0001
arm key
OG000
arm label
Treatment (Nonmyeloablative HCT, TBI)
regimen
Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
analyzed count
41
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01028716-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0002
arm key
OG000
arm label
Treatment (Nonmyeloablative HCT, TBI)
regimen
Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01028716-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0003
arm key
OG000
arm label
Treatment (Nonmyeloablative HCT, TBI)
regimen
Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01028716-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0004
arm key
OG000
arm label
Treatment (Nonmyeloablative HCT, TBI)
regimen
Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
analyzed count
45
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01028716-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01028716
outcome key
om-0005
arm key
OG000
arm label
Treatment (Nonmyeloablative HCT, TBI)
regimen
Conditioning: Fludarabine IV over 30-60 minutes daily on days -6 through -2 and cyclophosphamide IV over 1-2 hours on days -6, -5, and 3-4. Patients undergo total-body irradiation on day -1. Cell product: Patients undergo donor peripheral blood stem cell transplant on day 0. GVHD Prophylaxis: Patients then receive tacrolimus IV once daily or PO BID on days 5-180 (may be continued if active GvHD is present), mycophenolate mofetil IV or PO TID on days 5-35 (may be continued if GvHD present), and filgrastim IV beginning on day 5 until the ANC is \>= 1,000/mm\^3 for three consecutive days.
analyzed count
42
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01028716-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-acute-undifferentiated-leukemia
nct id
NCT01028716
harm key
EG000
source section id
NCT01028716-ae
event group key
EG000
event group label
Treatment (Nonmyeloablative HCT, TBI)
serious affected
4
serious at risk
45
other affected
44
other at risk
45
frequency threshold
0
collection period
Adverse events were collected for up to 100 days post HCT. Serious Adverse Events were collected until 1 year post-HCT. All cause mortality was assessed up to 3 years post 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