A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-t… (NCT06973668) | Clinical Trial Compass
RecruitingPhase 2
A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease
United States80 participantsStarted 2025-07-22
Plain-language summary
The goal of this clinical research study is to compare the effects of these drug combinations (cyclophosphamide, sirolimus, and MMF vs cyclophosphamide, sirolimus, and ruxolitinib) on the prevention of GVHD after a stem cell transplant.
Who can participate
Age range65 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age ≥ 65 and \< 75 years are eligible if they have one of the following diseases.
✓. Acute Myeloid Leukemia
✓. Myelodysplastic syndrome
✓. Chronic myelomonocytic leukemia
✓. Available HLA-identical or haploidentical related donor or a 7/8 or 8/8 HLA matched unrelated donor.
✓. Peripheral blood stem cells as a graft source
✓. Subject must voluntarily sign an informed consent.
✓. Adequate organ function per local laboratory reference range as follows: - Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0X ULN - Total Bilirubin \<1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of nonhepatic origin) - Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 40 mL/min/1.73 m2 (as reported in epic using 2021 CKD-EPI creatinine equation)
Exclusion criteria
✕. Subject is known to be positive for HIV.
✕. Subject has acute promyelocytic leukemia.
✕. Subject has known active CNS involvement with AML.
✕. Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI) score of \>5
✕
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
✕. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
✕. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative-, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or subjects with positive anti-HBc antibody but negative Hep B DNA may participate.
✕. Cardiac history of CHF requiring treatment or Ejection Fraction \< 50% or unstable angina or MI within 1 year of study entry