TriangleNCT00357565 · STUDY IN CONTEXT
Hematopoietic Stem Cell Transplantation in the Treatment of Infant 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
Defined as achieving donor derived neutrophil count \>500/uL by day 42 in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.
defined as death due to transplant
defined as platelet count \> 50,000
Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack.
Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack.
defined using standard criteria (bone marrow blast count and cytogenetics).
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
- NCT00357565
- trial label
- Hematopoietic Stem Cell Transplantation in the Treatment of Infant 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0000
- source section id
- NCT00357565-om-0000
- source outcome index
- 0
- endpoint
- Incidence of Engraftment
- endpoint definition
- Defined as achieving donor derived neutrophil count \>500/uL by day 42 in young children with leukemia or myelodysplastic syndrome undergoing a partially matched single unit umbilical cord blood transplant (UCBT) after a myeloablative preparative regimen consisting of busulfan, melphalan and fludarabine.
- time origin
- Day 42 After Transplant
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0001
- source section id
- NCT00357565-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Transplant-related Mortality (TRM)
- endpoint definition
- defined as death due to transplant
- time origin
- at 6 months after 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0002
- source section id
- NCT00357565-om-0002
- source outcome index
- 2
- endpoint
- Incidence of Platelet Engraftment
- endpoint definition
- defined as platelet count \> 50,000
- time origin
- at 1 year after 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0003
- source section id
- NCT00357565-om-0003
- source outcome index
- 3
- endpoint
- Incidence of Acute Graft-versus-host Disease (GVHD) Grade II-IV and Grade III-IV
- endpoint definition
- Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack.
- time origin
- Day 100 After 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0004
- source section id
- NCT00357565-om-0004
- source outcome index
- 4
- endpoint
- Incidence of Chronic Graft-versus-host Disease (GVHD)
- endpoint definition
- Graft-versus-host disease (GVHD) is a common complication of allogeneic bone marrow transplantation in which functional immune cells in the transplanted marrow recognize the recipient as "foreign" and mount an immunologic attack.
- time origin
- 1 Year After 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0005
- source section id
- NCT00357565-om-0005
- source outcome index
- 5
- endpoint
- Incidence of Relapse
- endpoint definition
- defined using standard criteria (bone marrow blast count and cytogenetics).
- time origin
- 1 and 2 years after 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Double Unit UCB Transplantation
- regimen
- Patients that receive 2 units of umbilical cord blood transplantation (UCBT).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Single Unit UCB Transplantation
- regimen
- Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0000
- arm key
- OG002
- arm label
- BM Transplantation
- regimen
- Blood and Marrow transplantation
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Double Unit UCB Transplantation
- regimen
- Patients that receive 2 units of umbilical cord blood transplantation (UCBT).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Single Unit UCB Transplantation
- regimen
- Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0001
- arm key
- OG002
- arm label
- BM Transplantation
- regimen
- Blood and Marrow transplantation
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0001#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Double Unit UCB Transplantation
- regimen
- Patients that receive 2 units of umbilical cord blood transplantation (UCBT).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Single Unit UCB Transplantation
- regimen
- Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0002
- arm key
- OG002
- arm label
- BM Transplantation
- regimen
- Blood and Marrow transplantation
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0002#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Double Unit UCB Transplantation
- regimen
- Patients that receive 2 units of umbilical cord blood transplantation (UCBT).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Single Unit UCB Transplantation
- regimen
- Patients that receive one unit of umbilical cord blood transplantation (only if 2 adequate size and matched units are not available).
- analyzed count
- 15
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- outcome key
- om-0003
- arm key
- OG002
- arm label
- BM Transplantation
- regimen
- Blood and Marrow transplantation
- analyzed count
- 4
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00357565-om-0003#groups/OG002
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- harm key
- EG000
- source section id
- NCT00357565-ae
- event group key
- EG000
- event group label
- Double Unit UCB Transplantation
- serious affected
- 8
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 0
- collection period
- 2 years
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- harm key
- EG001
- source section id
- NCT00357565-ae
- event group key
- EG001
- event group label
- Single Unit UCB Transplantation
- serious affected
- 5
- serious at risk
- 15
- other affected
- 15
- other at risk
- 15
- frequency threshold
- 0
- collection period
- 2 years
- 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-lymphoblastic-leukemia-pediatric
- nct id
- NCT00357565
- harm key
- EG002
- source section id
- NCT00357565-ae
- event group key
- EG002
- event group label
- BM Transplantation
- serious affected
- 1
- serious at risk
- 4
- other affected
- 4
- other at risk
- 4
- frequency threshold
- 0
- collection period
- 2 years
- 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