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

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

Recruiting
18 years and older
All
Phase 2

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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

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

Study details
    Hematologic Malignancies

NCT07359859

Memorial Sloan Kettering Cancer Center

31 January 2026

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