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

NCT07359859 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 25-212
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Hematologic Malignancies

Keywords

graft-versus-host disease (GVHD); allogeneic hematopoietic stem cell transplant (allo-HCT)

Outcome Measures

Primary Outcomes (1)

• assess cGVHD-free survival

  Chronic GVHD-free survival is defined as moderate-to-severe cGVHD requiring systemic immunosuppression treatment from the date of allo-HCT to first occurrence with follow-up through 12 months post-HCT or death.

  1 year post-HCT

Secondary Outcomes (1)

• incidence of grade 2-4 infections.

  1 year

Study Arms (2)

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

EXPERIMENTAL

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

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

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

ACTIVE COMPARATOR

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

Drug: Cyclophosphamide; Drug: Mycophenolate Mofetil; Drug: Tacrolimus

Interventions

Cyclophosphamide DRUG

An intermediate dose (medium dose) of Post-transplant Cyclophosphamide

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

Mycophenolate Mofetil DRUG

Day +5 to +35

Also known as: MMF

A full dose of PTCY, tacrolimus, and MMF (the standard GVHD prevention approach); An intermediate dose (medium dose) of PTCY, tacrolimus, MMF, and the drug ruxolitinib

Ruxolitinib DRUG

twice a day

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

Tacrolimus DRUG

Day +5, taper per SoC

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Incyte Corporation: collaborator

Study Sites (7)

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activites)

Rockville Centre, New York, 11553, United States

RECRUITING

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms; Graft vs Host Disease

Interventions

Cyclophosphamide; Mycophenolic Acid; ruxolitinib; Tacrolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Macrolides; Lactones

Study Officials

• Doris Ponce, MD, MS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Doris Ponce, MD, MS

CONTACT

646-608-3739; BMTTrials@mskcc.org

Brian Shaffer, MD

CONTACT

646-608-3737

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 22, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (7)