TriangleNCT03246906 · STUDY IN CONTEXT
Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
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
Composite time-to-event outcome in which events include moderate or severe chronic GVHD based on National Institute of Health consensus criteria, relapse, or death from any cause.
Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma w/ bullous formation and often w/ desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma w/ bullous formation and often w/ desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
GVHD occurring after day 100 and not meeting NIH consensus criteria for chronic GVHD. Estimated by cumulative incidence methods.
Estimated by cumulative incidence methods. Based on NIH consensus criteria.
Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL, MDS \>5% blasts by morphologic or flow cytometric evaluation of the BMA or appearance of extramedullary disease CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions
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
- NCT03246906
- trial label
- Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0000
- source section id
- NCT03246906-om-0000
- source outcome index
- 0
- endpoint
- Number of Patients With Chronic Graft Versus Host Disease (GVHD)-Free, Relapse-free Survival (CRFS)
- endpoint definition
- Composite time-to-event outcome in which events include moderate or severe chronic GVHD based on National Institute of Health consensus criteria, relapse, or death from any cause.
- time origin
- At 1 year post- hematopoietic cell transplantation (HCT)
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0001
- source section id
- NCT03246906-om-0001
- source outcome index
- 1
- endpoint
- Number of Patients With Grades II-IV Acute Graft Versus Host Disease (GVHD)
- endpoint definition
- Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma w/ bullous formation and often w/ desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
- time origin
- At day 100 post-HCT
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0002
- source section id
- NCT03246906-om-0002
- source outcome index
- 2
- endpoint
- Number of Patients With Grades III-IV Acute Graft Versus Host Disease (GVHD)
- endpoint definition
- Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma w/ bullous formation and often w/ desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
- time origin
- At day 100 post-HCT
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0003
- source section id
- NCT03246906-om-0003
- source outcome index
- 3
- endpoint
- Number of Patients With Late Graft Versus Host Disease (GVHD) Not Meeting National Institute of Health (NIH) Consensus Criteria for Chronic GVHD
- endpoint definition
- GVHD occurring after day 100 and not meeting NIH consensus criteria for chronic GVHD. Estimated by cumulative incidence methods.
- time origin
- At 1 year post-HCT
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0004
- source section id
- NCT03246906-om-0004
- source outcome index
- 4
- endpoint
- Number of Patients With Moderate and Severe Chronic Graft Versus Host Disease
- endpoint definition
- Estimated by cumulative incidence methods. Based on NIH consensus criteria.
- time origin
- At 1 year post-HCT
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0005
- source section id
- NCT03246906-om-0005
- source outcome index
- 5
- endpoint
- Number of Patients With Relapse/Progression
- endpoint definition
- Relapse/Progression criteria: CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL, MDS \>5% blasts by morphologic or flow cytometric evaluation of the BMA or appearance of extramedullary disease CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions
- time origin
- At 1 year post-HCT
- 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-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- regimen
- Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- regimen
- Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- regimen
- Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- regimen
- Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- regimen
- Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- regimen
- Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- regimen
- Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- regimen
- Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- regimen
- Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- regimen
- Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- regimen
- Patients undergo allogeneic HCT at day 0. Patients with an HLA-matched unrelated donor receive mycophenolate mofetil PO on days 0 to 40, cyclosporine PO every 12 hours BID on days -3 to 96 then tapered to day 150, and sirolimus PO QD on days -3 to day 150 then tapered to day 180. Patients with an HLA-mismatched donor receive mycophenolate mofetil PO on days 0-100 then tapered to day 150, cyclosporine PO BID on days -3 to 150 then tapered to day 180, and sirolimus PO QD on days -3 to 180 then tapered to day 365. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclosporine: Given PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
- analyzed count
- 73
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- regimen
- Patients undergo HCT at day 0. Patients with an HLA-matched unrelated donor receive cyclosporine PO BID on days 5-96 then tapered to day 150, sirolimus PO QD on days 5-150 then tapered to day 180, and cyclophosphamide IV on days 3 and 4. Patients with an HLA-mismatched donor receive cyclosporine PO BID on days 5-150 then tapered to day 180, sirolimus PO QD on days 5-180 then tapered to day 365, and cyclophosphamide IV on days 3 and 4. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo HCT Cyclophosphamide: Given IV Cyclosporine: Given PO Sirolimus: Given PO
- analyzed count
- 72
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03246906-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- harm key
- EG000
- source section id
- NCT03246906-ae
- event group key
- EG000
- event group label
- Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)
- serious affected
- 0
- serious at risk
- 73
- other affected
- 59
- other at risk
- 73
- frequency threshold
- 0
- collection period
- AEs & SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 1 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-prolymphocytic-leukemia
- nct id
- NCT03246906
- harm key
- EG001
- source section id
- NCT03246906-ae
- event group key
- EG001
- event group label
- Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)
- serious affected
- 1
- serious at risk
- 72
- other affected
- 63
- other at risk
- 72
- frequency threshold
- 0
- collection period
- AEs & SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 1 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