TriangleNCT00450450 · STUDY IN CONTEXT
Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
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
EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.
Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.
Death in a patient after transplant due to protocol treatment is defined as an TRM.
cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.
Median Time from transplant to neutrophil engraftment
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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- trial label
- Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0000
- source section id
- NCT00450450-om-0000
- source outcome index
- 0
- endpoint
- Estimated Two-year Event-free Survival (EFS)
- endpoint definition
- EFS is defined as relapse or treatment-related mortality (TRM). relapse is defined by either morphological or cytogenetic evidence of ALL consistent with pre-transplant features.
- time origin
- at 2 years
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Early terminated study. One patient is inevaluable for EFS on experimental arm and is excluded from analysis.
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0001
- source section id
- NCT00450450-om-0001
- source outcome index
- 1
- endpoint
- Estimated Graft Failure Rate
- endpoint definition
- Primary graft failure is defined as the failure to achieve an absolute neutrophil count of more than 5000 per cubic millimeter for at least three consecutive days by Day +42.
- time origin
- Up to 10 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient is inevaluable for EFS on experimental arm and is excluded from analysis.
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0002
- source section id
- NCT00450450-om-0002
- source outcome index
- 2
- endpoint
- Estimated Incidence of Grade III-IV Acute Graft-versus-host Disease (aGVHD)
- endpoint definition
- Stage III-IV aGVHD is defined as: Stage 0-3 skin, with Stage 2-3 liver, or Stage 2-3 GI; OR Stage 4 skin, liver or GI involvement.
- time origin
- Up to 3 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient is inevaluable and is excluded from analysis.
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0003
- source section id
- NCT00450450-om-0003
- source outcome index
- 3
- endpoint
- Estimated 100-day Transplant Related Mortality (TRM) Percentage
- endpoint definition
- Death in a patient after transplant due to protocol treatment is defined as an TRM.
- time origin
- 100 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient is inevaluable and is excluded from analysis.
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0004
- source section id
- NCT00450450-om-0004
- source outcome index
- 4
- endpoint
- Estimated Percentage of Chronic Graft-versus-host Disease (cGVHD)
- endpoint definition
- cGVHD definition is based on BMT CTN MOP SEPT. 2005; outlined in Protocol Appendix III.
- time origin
- 18 months post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Included only patients survived beyond 100 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0005
- source section id
- NCT00450450-om-0005
- source outcome index
- 5
- endpoint
- Estimated Median Time to Neutrophil Engraftment
- endpoint definition
- Median Time from transplant to neutrophil engraftment
- time origin
- Up to 10 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient was inevaluable and excluded from the analysis.
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Control BM Arm
- regimen
- Conventional bone marrow transplant (BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Experimental G-BM Arm
- regimen
- G-CSF (filgrastim) stimulated bone marrow (G-BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Control BM Arm
- regimen
- Conventional bone marrow transplant (BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Experimental G-BM Arm
- regimen
- G-CSF (filgrastim) stimulated bone marrow (G-BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Control BM Arm
- regimen
- Conventional bone marrow transplant (BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Experimental G-BM Arm
- regimen
- G-CSF (filgrastim) stimulated bone marrow (G-BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Control BM Arm
- regimen
- Conventional bone marrow transplant (BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Experimental G-BM Arm
- regimen
- G-CSF (filgrastim) stimulated bone marrow (G-BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Control BM Arm
- regimen
- Conventional bone marrow transplant (BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Experimental G-BM Arm
- regimen
- G-CSF (filgrastim) stimulated bone marrow (G-BM)
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Control BM Arm
- regimen
- Conventional bone marrow transplant (BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Experimental G-BM Arm
- regimen
- G-CSF (filgrastim) stimulated bone marrow (G-BM)
- analyzed count
- 13
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00450450-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- harm key
- EG000
- source section id
- NCT00450450-ae
- event group key
- EG000
- event group label
- Control BM Arm
- serious affected
- 1
- serious at risk
- 13
- other affected
- 8
- other at risk
- 13
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13.
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00450450
- harm key
- EG001
- source section id
- NCT00450450-ae
- event group key
- EG001
- event group label
- Experimental G-BM Arm
- serious affected
- 0
- serious at risk
- 13
- other affected
- 7
- other at risk
- 13
- frequency threshold
- 0
- collection period
- Source null
- event definition
- Group 2 enrollment total is 14, patient 774353 enrolled on study, but was not randomized and didn't contribute any data. Group 2 AE total is 13.
- 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