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NCT07359859PHASE2Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

1/20/2026

Completion Date

1/1/2029

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 Criteria

Age Range: 18 years to No maximum

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) * Patients with an active secondary malignancy or prior malignancy requiring systemic therapy within the past 5 years. Exceptions include adequately treated localized non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma), as well as localized prostate cancer considered low risk and stable under treatment or surveillance. * 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

Interventions

DRUG

Cyclophosphamide

DRUG

Cyclophosphamide

DRUG

Mycophenolate Mofetil

DRUG

Ruxolitinib

DRUG

Tacrolimus

DRUG

Tacrolimus

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Conditions

Hematologic Malignancies

Locations

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York 11553

United States