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
Number of Patients With Overall Survival at 2 Years.
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.
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.
Number of patients that have disease recurrence.
Number of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.
Reported safety
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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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-myeloproliferative-neoplasms
- 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
Triangle