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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Source null

→

secondary · POSTED

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

Source null

→

secondary · POSTED

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

Source null

→

secondary · POSTED

GVHD occurring after day 100 and not meeting NIH consensus criteria for chronic GVHD. Estimated by cumulative incidence methods.

Source null

→

secondary · POSTED

Estimated by cumulative incidence methods. Based on NIH consensus criteria.

Source null

→

secondary · POSTED

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

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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-blastic-plasmacytoid-dendritic-cell-neoplasm
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