TriangleNCT02793544 · STUDY IN CONTEXT
HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide
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
Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
Time from HCT until the documentation of disease progression / relapse or death due to any cause, whichever occurs first. Progression-free survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
Death without evidence of disease progression or recurrence. A cumulative incidence will be computed along with a 90% CI.
Achieving a donor derived ANC ≥ 500/mm3 for 3 consecutive laboratory values on different days. A cumulative incidence will be computed along with a 90% CI.
Achieving a platelet count ≥ 20,000/μL for 3 consecutive laboratory values on different days (with no platelet transfusions in the preceding seven days). A cumulative incidence will be computed along with a 90% CI.
Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI. Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.
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-undifferentiated-leukemia
- nct id
- NCT02793544
- trial label
- HLA-Mismatched Unrelated Donor Bone Marrow Transplantation With Post-Transplantation Cyclophosphamide
- 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-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0000
- source section id
- NCT02793544-om-0000
- source outcome index
- 0
- endpoint
- Overall Survival
- endpoint definition
- Death from any cause. The time to this event is the time from HCT to death, loss to follow-up, or end of study (whichever comes first). The overall survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
- time origin
- 365 days 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-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0001
- source section id
- NCT02793544-om-0001
- source outcome index
- 1
- endpoint
- Progression-free Survival
- endpoint definition
- Time from HCT until the documentation of disease progression / relapse or death due to any cause, whichever occurs first. Progression-free survival probability and 90% CI will be calculated by the Kaplan Meier product limit estimator.
- time origin
- 180 days and 365 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-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0002
- source section id
- NCT02793544-om-0002
- source outcome index
- 2
- endpoint
- Transplant-related Mortality
- endpoint definition
- Death without evidence of disease progression or recurrence. A cumulative incidence will be computed along with a 90% CI.
- time origin
- 100 days, 180 days, and 365 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-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0003
- source section id
- NCT02793544-om-0003
- source outcome index
- 3
- endpoint
- Cumulative Incidence of Neutrophil Recovery
- endpoint definition
- Achieving a donor derived ANC ≥ 500/mm3 for 3 consecutive laboratory values on different days. A cumulative incidence will be computed along with a 90% CI.
- time origin
- 100 days and 365 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-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0004
- source section id
- NCT02793544-om-0004
- source outcome index
- 4
- endpoint
- Cumulative Incidence of Platelet Recovery
- endpoint definition
- Achieving a platelet count ≥ 20,000/μL for 3 consecutive laboratory values on different days (with no platelet transfusions in the preceding seven days). A cumulative incidence will be computed along with a 90% CI.
- time origin
- 100 days and 365 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-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0005
- source section id
- NCT02793544-om-0005
- source outcome index
- 5
- endpoint
- Cumulative Incidence of Acute GVHD
- endpoint definition
- Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades II-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI. Any skin, gastrointestinal or liver abnormalities fulfilling the BMT CTN Manual of Operations (2013) criteria of grades III-IV acute GVHD. A cumulative incidence will be computed along with a 90% CI.
- 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-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Myeloablative Conditioning (MAC)
- regimen
- Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Reduced Intensity Conditioning (RIC)
- regimen
- Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Myeloablative Conditioning (MAC)
- regimen
- Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Reduced Intensity Conditioning (RIC)
- regimen
- Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Myeloablative Conditioning (MAC)
- regimen
- Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Reduced Intensity Conditioning (RIC)
- regimen
- Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Myeloablative Conditioning (MAC)
- regimen
- Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Reduced Intensity Conditioning (RIC)
- regimen
- Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Myeloablative Conditioning (MAC)
- regimen
- Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Reduced Intensity Conditioning (RIC)
- regimen
- Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Myeloablative Conditioning (MAC)
- regimen
- Participants received one of three regimens: cyclophosphamide and total body irradiation; busulfan and cyclophosphamide; or fludarabine and busulfan
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Reduced Intensity Conditioning (RIC)
- regimen
- Participants received one of two regimens: fludarabine, cyclophosphamide, and low-dose total body irradiation
- analyzed count
- 40
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02793544-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-acute-undifferentiated-leukemia
- nct id
- NCT02793544
- harm key
- EG000
- source section id
- NCT02793544-ae
- event group key
- EG000
- event group label
- Myeloablative Conditioning (MAC)
- serious affected
- 12
- serious at risk
- 40
- other affected
- 5
- other at risk
- 40
- frequency threshold
- 0
- collection period
- Up to 1 year post transplant
- event definition
- Evaluation of toxicities will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTCAE version 4.03. The protocol pre-specifies that Adverse Events on this study are reported and evaluated by conditioning regimen arm (MAC or RIC).
- 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-undifferentiated-leukemia
- nct id
- NCT02793544
- harm key
- EG001
- source section id
- NCT02793544-ae
- event group key
- EG001
- event group label
- Reduced Intensity Conditioning (RIC)
- serious affected
- 13
- serious at risk
- 40
- other affected
- 0
- other at risk
- 40
- frequency threshold
- 0
- collection period
- Up to 1 year post transplant
- event definition
- Evaluation of toxicities will be graded using National Cancer Institute Common Toxicity Criteria, specifically CTCAE version 4.03. The protocol pre-specifies that Adverse Events on this study are reported and evaluated by conditioning regimen arm (MAC or RIC).
- 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