Trial Outcomes & Findings for Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation (NCT NCT03246906)

Last Updated: 2026-05-14

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

At 1 year post- hematopoietic cell transplantation (HCT)

Results posted on

2026-05-14

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) 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
Overall Study STARTED	75	75
Overall Study COMPLETED	73	72
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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	Total n=145 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	1 Participants n=1512 Participants	1 Participants n=504 Participants	2 Participants n=2016 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Age, Categorical <=18 years	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=1512 Participants	30 Participants n=504 Participants	62 Participants n=2016 Participants
Age, Categorical >=65 years	41 Participants n=1512 Participants	42 Participants n=504 Participants	83 Participants n=2016 Participants
Age, Continuous	66.3 years n=1512 Participants	67.6 years n=504 Participants	66.4 years n=2016 Participants
Sex: Female, Male Female	28 Participants n=1512 Participants	30 Participants n=504 Participants	58 Participants n=2016 Participants
Sex: Female, Male Male	45 Participants n=1512 Participants	42 Participants n=504 Participants	87 Participants n=2016 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=1512 Participants	0 Participants n=504 Participants	5 Participants n=2016 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	65 Participants n=1512 Participants	71 Participants n=504 Participants	136 Participants n=2016 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=1512 Participants	1 Participants n=504 Participants	4 Participants n=2016 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=1512 Participants	0 Participants n=504 Participants	1 Participants n=2016 Participants
Race (NIH/OMB) Asian	3 Participants n=1512 Participants	4 Participants n=504 Participants	7 Participants n=2016 Participants
Race (NIH/OMB) White	67 Participants n=1512 Participants	66 Participants n=504 Participants	133 Participants n=2016 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=1512 Participants	1 Participants n=504 Participants	2 Participants n=2016 Participants
Region of Enrollment United States	73 participants n=1512 Participants	72 participants n=504 Participants	145 participants n=2016 Participants

PRIMARY outcome

Timeframe: At 1 year post- hematopoietic cell transplantation (HCT)

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.

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Chronic Graft Versus Host Disease (GVHD)-Free, Relapse-free Survival (CRFS)	38 Participants	54 Participants

SECONDARY outcome

Timeframe: At day 100 post-HCT

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

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Grades II-IV Acute Graft Versus Host Disease (GVHD)	31 Participants	29 Participants

SECONDARY outcome

Timeframe: At day 100 post-HCT

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Grades III-IV Acute Graft Versus Host Disease (GVHD)	7 Participants	4 Participants

SECONDARY outcome

Timeframe: At 1 year post-HCT

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

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Late Graft Versus Host Disease (GVHD) Not Meeting National Institute of Health (NIH) Consensus Criteria for Chronic GVHD	2 Participants	4 Participants

SECONDARY outcome

Timeframe: At 1 year post-HCT

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

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Moderate and Severe Chronic Graft Versus Host Disease	23 Participants	1 Participants

SECONDARY outcome

Timeframe: At 1 year post-HCT

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

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Relapse/Progression	10 Participants	11 Participants

SECONDARY outcome

Timeframe: At 1 year post-HCT

Number of subjects expired without disease progression/relapse.

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Non-relapse Mortalities	5 Participants	7 Participants

SECONDARY outcome

Timeframe: At 1 year post-HCT

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients With Progression or Relapse-free Survival	58 Participants	54 Participants

SECONDARY outcome

Timeframe: At 1 year post-HCT

Number of subjects surviving overall post-transplant.

Outcome measures

Outcome measures
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 Participants 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 Participants 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
Number of Patients Surviving Overall	62 Participants	62 Participants

Adverse Events

Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus)

Serious events: 0 serious events

Other events: 59 other events

Deaths: 11 deaths

Arm II (Cyclosporine, Sirolimus, Cyclophosphamide)

Serious events: 1 serious events

Other events: 63 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Arm I (Mycophenolate Mofetil, Cyclosporine, Sirolimus) n=73 participants at risk 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	Arm II (Cyclosporine, Sirolimus, Cyclophosphamide) n=72 participants at risk 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
Skin and subcutaneous tissue disorders Angioedema	0.00% 0/73 • AEs & SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 1 Year.	1.4% 1/72 • Number of events 1 • AEs & SAEs: Conditioning through Day 100; All-Cause Mortality: Conditioning through 1 Year.

Other adverse events

Additional Information

Dr. Masumi Ueda Oshima

Fred Hutch Cancer Center

Phone: (206) 667-4546

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place