TriangleNCT01621477 · STUDY IN CONTEXT
T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite P
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
Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.
Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.
Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.
Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.
The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.
The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.
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-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- trial label
- T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite P
- 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
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0000
- source section id
- NCT01621477-om-0000
- source outcome index
- 0
- endpoint
- One-year Survival (OS)
- endpoint definition
- Evaluate the number of participants alive at 1 year. The number of participants surviving to one-year post-transplantation is given.
- time origin
- One year post 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-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0001
- source section id
- NCT01621477-om-0001
- source outcome index
- 1
- endpoint
- Incidence of Malignant Relapse
- endpoint definition
- Estimate the incidence of malignant relapse at one year post-transplant. The number of participants with malignant relapse or progressive disease is given. Relapse was evaluated using standard WHO criteria for each disease.
- time origin
- One year post 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0002
- source section id
- NCT01621477-om-0002
- source outcome index
- 2
- endpoint
- Event-Free Survival (EFS)
- endpoint definition
- Estimate the EFS at one-year post-transplantation. The event is defined as relapse or death due to any cause. The number of participants who were alive without relapse at one year post-transplant is reported.
- time origin
- one year 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-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0003
- source section id
- NCT01621477-om-0003
- source outcome index
- 3
- endpoint
- Disease-Free Survival (DFS)
- endpoint definition
- Estimate the DFS at one-year post-transplantation. The event is defined as relapse or death due to relapse. The number of participants who did not relapse up to one year post transplant is reported.
- time origin
- one year 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-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0004
- source section id
- NCT01621477-om-0004
- source outcome index
- 4
- endpoint
- Incidence and Severity of Acute Graft Versus Host Disease (GVHD)
- endpoint definition
- The number of participants with acute GVHD is given, organized by grade. Participants are graded on a scale from 1 to 4, with 1 being mild and 4 being severe.
- time origin
- 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-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0005
- source section id
- NCT01621477-om-0005
- source outcome index
- 5
- endpoint
- Incidence and Severity of Chronic Graft Versus Host Disease (GVHD)
- endpoint definition
- The severity of chronic GVHD will be described. Chronic GVHD was evaluated using NIH Consensus Global Severity Scoring. The number of participants with chronic GVHD is given, organized by severity.
- time origin
- 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-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment
- regimen
- Study participants (excluding donors) who were enrolled and underwent transplant.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01621477-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment
- regimen
- Study participants (excluding donors) who were enrolled and underwent transplant.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01621477-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment
- regimen
- Study participants (excluding donors) who were enrolled and underwent transplant.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01621477-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment
- regimen
- Study participants (excluding donors) who were enrolled and underwent transplant.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01621477-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment
- regimen
- Study participants (excluding donors) who were enrolled and underwent transplant.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01621477-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment
- regimen
- Study participants (excluding donors) who were enrolled and underwent transplant.
- analyzed count
- 17
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01621477-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-juvenile-myelomonocytic-leukemia
- nct id
- NCT01621477
- harm key
- EG000
- source section id
- NCT01621477-ae
- event group key
- EG000
- event group label
- Treatment
- serious affected
- 10
- serious at risk
- 17
- other affected
- 17
- other at risk
- 17
- frequency threshold
- 0
- collection period
- Participants were followed for adverse events from the start of conditioning therapy and throughout the first year post hematopoietic cell transplant (HCT).
- 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