A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant
Randomized Pilot Study of Ruxolitinib for Switch-Maintenance Prophylaxis of Graft-versus-Host Disease in Allogeneic Hematopoietic Cell Transplantation After Intermediate-Dose Post-Transplant Cyclophosphamide (Rux Switch-Maintenance in Intermediate PTCY: RuSMa-PTCY) in Comparison to Full-Dose PTCY
Memorial Sloan Kettering Cancer Center
40 participants
Jan 20, 2026
INTERVENTIONAL
Conditions
Summary
The researchers are doing this study to compare 2 different GVHD prevention (prophylaxis) approaches. The researchers will see which approach is good or more effective at preventing chronic GVHD until 1 year after allogeneic hematopoietic stem cell transplantation (allo-HCT).
Eligibility
Inclusion Criteria7
- Patients ≥18- years-old at time of consent
- Diagnosis: hematologic malignancy in morphologic remission (blasts <5%, no evidence of extramedullary disease in AML or MDS). Patients with CR with incomplete count recovery (CRp or CRi) or minimal residual disease are allowed. Patients with lymphoma must have a complete or partial response
- Donor: related or unrelated 7-8/8 HLA-matched or related haploidentical
- Karnofsky score ≥ 70%
- Female subjects of childbearing potential (<50 years old) have a negative serum or urine pregnancy test. Females of childbearing potential are defined as females without prior hysterectomy or who have had any evidence of menses in the past 12 months.
- °Sexually active females of childbearing potential enrolled in the study must agree to consistently use two forms of accepted methods of contraception during the course of the study and for 3 months after their last dose of the study drug. Effective birth control includes: *Intrauterine device (IUD) plus one barrier method *Stable doses of hormonal contraception for at least 3 months (e.g., oral, injectable, implant, transdermal) plus one barrier method *2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gel that contain a chemical to kill sperm); or * A vasectomized partner.
- For male subjects who are sexually active and who are partners of females of childbearing potential: Agreement to use two forms of contraception as per above and to not donate sperm during the treatment period and for at least 3 months after the last dose of study drug
Exclusion Criteria8
- Recipient of CD34+ selected or engineered stem cell graft
- Treatment with in vivo T cell depletion (e.g. anti-thymocyte globulin)
- Severely impaired renal function defined by serum creatinine > 2mg/dL, renal dialysis requirement.
- Use of investigational agent within 14 days pre-HCT
- Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
- Uncontrolled psychiatric illness
- Female patient who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib
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Interventions
An intermediate dose (medium dose) of Post-transplant Cyclophosphamide
A full dose of Post-transplant Cyclophosphamide
Day +5 to +35
twice a day
Day +5, taper per SoC
Day +5, taper initiation within 2 weeks of starting Ruxolitinib
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT07359859