NCT01839916 · STUDY IN CONTEXT
Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
Estimated by cumulative incidence method.
Estimated by cumulative incidence method.
Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- trial label
- Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
- applicability
- unclear
- applicability note
- Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0000
- source section id
- NCT01839916-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
- endpoint definition
- Percentage of Patients Who Are Able to Receive at Least One DLI Treatment
- time origin
- Up to 2 years
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0001
- source section id
- NCT01839916-om-0001
- source outcome index
- 1
- endpoint
- Progression Free Survival (PFS)
- endpoint definition
- Time to relapse or death as a result of any cause was evaluated at 2 years and the progression free survival rate was reported.
- time origin
- 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients received at least one DLI Treatment.
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0002
- source section id
- NCT01839916-om-0002
- source outcome index
- 2
- endpoint
- Overall Survival (OS)
- endpoint definition
- Computed using the Kaplan-Meier product-limit estimate and expressed as probabilities with a 95% CI.
- time origin
- At 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients received at least one DLI Treatment.
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0003
- source section id
- NCT01839916-om-0003
- source outcome index
- 3
- endpoint
- Rate of Acute GVHD (aGVHD) With Any Grade
- endpoint definition
- Estimated by cumulative incidence method.
- time origin
- At 1 year and 2 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients received at least one DLI Treatment.
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0004
- source section id
- NCT01839916-om-0004
- source outcome index
- 4
- endpoint
- Rate of Chronic GVHD (cGVHD)
- endpoint definition
- Estimated by cumulative incidence method.
- time origin
- At 1 year and 2 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients received at least one DLI treatment.
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0005
- source section id
- NCT01839916-om-0005
- source outcome index
- 5
- endpoint
- Treatment-related Mortality
- endpoint definition
- Estimated by cumulative incidence method. Cumulative incidence of treatment-related mortality with relapse of the original disease as the competing risk will be calculated.
- time origin
- At 2 year
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Patients received at least one DLI treatment.
- 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-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 77
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01839916-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01839916-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01839916-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01839916-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01839916-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Treatment (DLI)
- regimen
- Patients receive DLI IV. Treatment repeats every 4-8 weeks for 5 doses in the absence of disease progression or unacceptable toxicity. therapeutic allogeneic lymphocytes: Given IV laboratory biomarker analysis: Correlative studies
- analyzed count
- 36
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01839916-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-hodgkin-lymphoma-pediatric-refractory-07b44757
- nct id
- NCT01839916
- harm key
- EG000
- source section id
- NCT01839916-ae
- event group key
- EG000
- event group label
- Treatment (DLI)
- serious affected
- 12
- serious at risk
- 36
- other affected
- 1
- other at risk
- 36
- frequency threshold
- 0
- collection period
- 2 year
- 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
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