NCT00054327 · STUDY IN CONTEXT

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer

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

Number of Patients With Overall Survival at 2 Years.

Source null

→

primary · POSTED

Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.

Source null

→

secondary · POSTED

Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.

Source null

→

secondary · POSTED

Number of patients that have disease recurrence.

Source null

→

secondary · POSTED

Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.

Source null

→

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-myelodysplastic-syndromes
nct id: NCT00054327
trial label: Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
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: 5
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0004
source section id
NCT00054327-om-0004
source outcome index
4
endpoint
Number of Patients With Overall Survival at 2 Years.
endpoint definition
Number of Patients With Overall Survival at 2 Years.
time origin
at 2 years from transplant
analysis role
post-hoc
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-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
source section id
NCT00054327-om-0000
source outcome index
0
endpoint
Rates of Durable Engraftment
endpoint definition
Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.
time origin
at day 42
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-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
source section id
NCT00054327-om-0001
source outcome index
1
endpoint
Graft-versus-host Disease (GVHD)
endpoint definition
Number of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.
time origin
at 100 days 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-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0002
source section id
NCT00054327-om-0002
source outcome index
2
endpoint
Incidence of Recurrent Disease
endpoint definition
Number of patients that have disease recurrence.
time origin
at day 100 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-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0003
source section id
NCT00054327-om-0003
source outcome index
3
endpoint
Toxicity as Measured by CTC v2.0
endpoint definition
Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.
time origin
at 100 days 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-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
arm key
OG000
arm label
Regimen A
regimen
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
arm key
OG001
arm label
Regimen B-1
regimen
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
arm key
OG002
arm label
Regimen B-2
regimen
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
arm key
OG003
arm label
Regimen B-3
regimen
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
arm key
OG004
arm label
Regimen C
regimen
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0000
arm key
OG005
arm label
Regimen D
regimen
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
arm key
OG000
arm label
Regimen A
regimen
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
arm key
OG001
arm label
Regimen B-1
regimen
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
arm key
OG002
arm label
Regimen B-2
regimen
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
analyzed count
3
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
arm key
OG003
arm label
Regimen B-3
regimen
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
analyzed count
4
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
arm key
OG004
arm label
Regimen C
regimen
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
analyzed count
10
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
outcome key
om-0001
arm key
OG005
arm label
Regimen D
regimen
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00054327-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-myelodysplastic-syndromes
nct id
NCT00054327
harm key
EG000
source section id
NCT00054327-ae
event group key
EG000
event group label
Regimen A
serious affected
0
serious at risk
11
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
event definition
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
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-myelodysplastic-syndromes
nct id
NCT00054327
harm key
EG001
source section id
NCT00054327-ae
event group key
EG001
event group label
Regimen B-1
serious affected
0
serious at risk
4
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
event definition
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
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-myelodysplastic-syndromes
nct id
NCT00054327
harm key
EG002
source section id
NCT00054327-ae
event group key
EG002
event group label
Regimen B-2
serious affected
1
serious at risk
3
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
event definition
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
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-myelodysplastic-syndromes
nct id
NCT00054327
harm key
EG003
source section id
NCT00054327-ae
event group key
EG003
event group label
Regimen B-3
serious affected
2
serious at risk
4
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
event definition
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
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-myelodysplastic-syndromes
nct id
NCT00054327
harm key
EG004
source section id
NCT00054327-ae
event group key
EG004
event group label
Regimen C
serious affected
2
serious at risk
10
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
event definition
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
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-myelodysplastic-syndromes
nct id
NCT00054327
harm key
EG005
source section id
NCT00054327-ae
event group key
EG005
event group label
Regimen D
serious affected
0
serious at risk
2
other affected
0
other at risk
0
frequency threshold
0
collection period
Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
event definition
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
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