A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07359859

This study evaluates two GVHD prophylaxis strategies post-allo-HCT in patients with hematologic malignancies in remission. Eligible participants are adults with a Karnofsky score ≥70% and specific contraceptive measures. Interventions include varying doses of Cyclophosphamide, Mycophenolate Mofetil, Ruxolitinib, and Tacrolimus, with specific administration schedules.

Patient Parameters

Program Overview

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 Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering Westchester (Limited Protocol Activities)10604HarrisonNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)10065New YorkNew York
Memorial Sloan Kettering Nassau (Limited Protocol Activites)11553Rockville CentreNew York

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