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 (MSK)

Status and phase: Enrolling; Phase 2

Conditions: Hematologic Malignancies

Treatments: Drug: Ruxolitinib; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07359859

25-212

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib

Experimental group

Description:

will receive an intermediate (medium) dose of PTCY, tacrolimus, MMF,and ruxolitinib

Treatment:

Drug: Mycophenolate Mofetil

Drug: Tacrolimus

Drug: Tacrolimus

Drug: Cyclophosphamide

Drug: Ruxolitinib

Drug: Cyclophosphamide

A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)

Active Comparator group

Description:

will receive a full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach)

Treatment:

Drug: Mycophenolate Mofetil

Drug: Tacrolimus

Drug: Tacrolimus

Drug: Cyclophosphamide

Drug: Cyclophosphamide