TriangleNCT04191187 · STUDY IN CONTEXT
Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies
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
Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.
GVHD-free survival is defined as the time from the date of PBSCT to date of events which include grade III-IV acute GVHD and systemic therapy-requiring chronic GVHD.
OS is defined as the time from the date of PBSCT to the date of death due to any cause.
TRM is defined as death not directly due to disease
TRM is defined as death not directly due to disease
RFS is defined as the time from the date of PBSCT to relapse or death.
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-prolymphocytic-leukemia
- nct id
- NCT04191187
- trial label
- Reduced Intensity Flu/Mel/TBI Conditioning for HAPLO HCT Patients With Hematologic Malignancies
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0000
- source section id
- NCT04191187-om-0000
- source outcome index
- 0
- endpoint
- Disease Free Survival
- endpoint definition
- Disease Free Survival (DFS) is defined as the time from the date of Peripheral Blood Stem Cell Transplant (PBSCT) to first documentation of relapse or death due to any cause, whichever comes first.
- time origin
- Up to 18 months post-transplant
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable Participants
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0001
- source section id
- NCT04191187-om-0001
- source outcome index
- 1
- endpoint
- Percentage of Participants With Graft vs Host Disease (GVHD) Free Survival
- endpoint definition
- GVHD-free survival is defined as the time from the date of PBSCT to date of events which include grade III-IV acute GVHD and systemic therapy-requiring chronic GVHD.
- time origin
- At 180 days post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable Participants
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0002
- source section id
- NCT04191187-om-0002
- source outcome index
- 2
- endpoint
- Percentage of Participants Overall Survival (OS)
- endpoint definition
- OS is defined as the time from the date of PBSCT to the date of death due to any cause.
- time origin
- Up to 18 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable Participants
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0003
- source section id
- NCT04191187-om-0003
- source outcome index
- 3
- endpoint
- Percentage of Participants With Treatment Related Mortality (TRM) at 6 Months
- endpoint definition
- TRM is defined as death not directly due to disease
- time origin
- at 6 months post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable Participants
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0004
- source section id
- NCT04191187-om-0004
- source outcome index
- 4
- endpoint
- Percentage of Participants With Treatment Related Mortality (TRM) at 18 Months
- endpoint definition
- TRM is defined as death not directly due to disease
- time origin
- at 18 months post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable Participants
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0005
- source section id
- NCT04191187-om-0005
- source outcome index
- 5
- endpoint
- Percentage of Participants With Relapse Free Survival (RFS)
- endpoint definition
- RFS is defined as the time from the date of PBSCT to relapse or death.
- time origin
- Up to 18 months post-transplant
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Evaluable Participants
- 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-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Conditioning Regimen + Transplant
- regimen
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04191187-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Conditioning Regimen + Transplant
- regimen
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04191187-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Conditioning Regimen + Transplant
- regimen
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04191187-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Conditioning Regimen + Transplant
- regimen
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04191187-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Conditioning Regimen + Transplant
- regimen
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04191187-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04191187
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Conditioning Regimen + Transplant
- regimen
- All participants will receive a conditioning regimen of Fludarabine, Melphalan and Total Body Irradiation prior to transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) Fludarabine: Fludarabine 30mg/m\^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m\^2 Melphalan: Melphalan 70 mg/m\^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight. Total Body Irradiation: Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
- analyzed count
- 34
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT04191187-om-0005#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT04191187
- harm key
- EG000
- source section id
- NCT04191187-ae
- event group key
- EG000
- event group label
- Conditioning Regimen + Transplant
- serious affected
- 21
- serious at risk
- 34
- other affected
- 16
- other at risk
- 34
- frequency threshold
- 0
- collection period
- All events beginning with start of study intervention until 30 days after the last day of study intervention (up to 36 months) will be reported.
- 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