TriangleNCT00322101 · STUDY IN CONTEXT
Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
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
Overall Survival
IWG criteria was used to determine disease progression
Non-relapse Mortality
Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.
Disease progression/relapse was defined by IWG criteria
Incidence and Severity of Acute and Chronic Graft-vs-host Disease
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-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- trial label
- Low-Dose or High-Dose Conditioning Followed by Peripheral Blood Stem Cell Transplant in Treating Patients With Myelodysplastic Syndrome or Acute Myelogenous Leukemia
- 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
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0000
- source section id
- NCT00322101-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Overall Survival
- time origin
- At 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent
- 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-pediatric
- nct id
- NCT00322101
- outcome key
- om-0001
- source section id
- NCT00322101-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival
- endpoint definition
- IWG criteria was used to determine disease progression
- time origin
- After stem cell infusion to date of last follow up.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 2 patients in the nonmyeloablative arm did not receive a transplant due to relapse and withdrawal of consent
- 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-pediatric
- nct id
- NCT00322101
- outcome key
- om-0002
- source section id
- NCT00322101-om-0002
- source outcome index
- 2
- endpoint
- Non-relapse Mortality
- endpoint definition
- Non-relapse Mortality
- time origin
- At 100 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 2 patients in the nonmyeloablative arm did not receive transplant due to relapse and withdrawal of consent
- 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-pediatric
- nct id
- NCT00322101
- outcome key
- om-0003
- source section id
- NCT00322101-om-0003
- source outcome index
- 3
- endpoint
- Donor Cell Engraftment
- endpoint definition
- Chimerism analysis was performed in patients who recieved nonmyeloablative tranplsnat. In this group the definition of engraftment was a CD3 count greater than 50%. In the myeloablative group, engraftment was defined as an absolute neutrophil count greater than 50%.
- time origin
- After stem cell infusion to day 28
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- 2 patients who were randomized to receive nonmyeloablative conditioning did not undergo transplant due to relapse and withdrawal of consent
- 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-pediatric
- nct id
- NCT00322101
- outcome key
- om-0004
- source section id
- NCT00322101-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Disease Progression/Relapse
- endpoint definition
- Disease progression/relapse was defined by IWG criteria
- time origin
- After stem cell infusion to date of last follow up.
- 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-pediatric
- nct id
- NCT00322101
- outcome key
- om-0005
- source section id
- NCT00322101-om-0005
- source outcome index
- 5
- endpoint
- Incidence and Severity of Acute and Chronic Graft-vs-host Disease
- endpoint definition
- Incidence and Severity of Acute and Chronic Graft-vs-host Disease
- time origin
- After transplantation
- 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-pediatric
- nct id
- NCT00322101
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Nonmyeloablative Regimen)
- regimen
- CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Myeloablative Regimen)
- regimen
- CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Nonmyeloablative Regimen)
- regimen
- CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Myeloablative Regimen)
- regimen
- CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Nonmyeloablative Regimen)
- regimen
- CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Myeloablative Regimen)
- regimen
- CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (Nonmyeloablative Regimen)
- regimen
- CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (Myeloablative Regimen)
- regimen
- CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (Nonmyeloablative Regimen)
- regimen
- CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (Myeloablative Regimen)
- regimen
- CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (Nonmyeloablative Regimen)
- regimen
- CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96.
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (Myeloablative Regimen)
- regimen
- CONDITIONING: Patients are assigned to 1 of 2 treatment groups. Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2. Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4. TRANSPLANTATION: Patients undergo PBSC infusion on day 0. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00322101-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- harm key
- EG000
- source section id
- NCT00322101-ae
- event group key
- EG000
- event group label
- Arm I (Nonmyeloablative Regimen)
- serious affected
- 3
- serious at risk
- 12
- other affected
- 12
- other at risk
- 12
- frequency threshold
- 5
- collection period
- Source null
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-myeloid-leukemia-pediatric
- nct id
- NCT00322101
- harm key
- EG001
- source section id
- NCT00322101-ae
- event group key
- EG001
- event group label
- Arm II (Myeloablative Regimen)
- serious affected
- 4
- serious at risk
- 11
- other affected
- 11
- other at risk
- 11
- frequency threshold
- 5
- collection period
- Source null
- 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