Actively Recruiting
Randomized Pilot Study of Ruxolitinib for Preventing Graft-versus-Host Disease After Stem Cell Transplant in Hematologic Malignancies Comparing Intermediate vs Full-Dose Post-Transplant Cyclophosphamide
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-27
40
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two different approaches to prevent chronic graft-versus-host disease (GVHD) in people with blood cancers who are receiving an allogeneic hematopoietic stem cell transplant (allo-HCT). The study aims to find out which prevention method is better at avoiding chronic GVHD up to one year after transplant. This is a Phase 2 randomized study sponsored by Memorial Sloan Kettering Cancer Center. Participants will be randomly assigned to one of two treatment groups. One group will receive an intermediate dose of post-transplant cyclophosphamide (PTCY), tacrolimus, mycophenolate mofetil (MMF), and ruxolitinib taken twice daily. The other group will receive the standard approach with a full dose of PTCY, tacrolimus, and MMF. Tacrolimus is started on day 5, with tapering schedules based on standard care or starting within two weeks of ruxolitinib. MMF is given from day 5 to day 35. During the study, participants will be closely monitored for chronic GVHD-free survival up to one year after transplant. Researchers will also track infections of grade 2 to 4 during that time. The study involves regular clinical assessments, laboratory tests, and safety monitoring. Participation will last at least one year after the stem cell transplant, allowing comprehensive evaluation of treatment effects and side effects over time.
CONDITIONS
Brief Title
A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older at time of consent
- Diagnosis of hematologic malignancy in remission or with minimal residual disease
- Donor is related or unrelated 7-8/8 HLA-matched or related haploidentical
- Karnofsky performance score of 70% or higher
- Female participants under 50 years old must have negative pregnancy test and agree to use two forms of contraception during study and for 3 months after
- Male participants sexually active with females of childbearing potential must agree to use two forms of contraception and avoid sperm donation during treatment and for 3 months after
You will not qualify if you...
- Recipient of CD34+ selected or engineered stem cell graft
- Prior treatment with in vivo T cell depletion agents such as anti-thymocyte globulin
- Any other active cancer within 3 years except certain treated skin cancers
- Severe kidney impairment or on dialysis
- Use of investigational agents within 14 days before transplant
- Current uncontrolled heart conditions or recent heart attack
- Uncontrolled psychiatric illness
- Female who is pregnant or breastfeeding
- Known allergy or sensitivity to ruxolitinib
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 month starting from transplant day
Participants receive post-transplant treatment including an intermediate or full dose of cyclophosphamide, tacrolimus, mycophenolate mofetil, and for some, ruxolitinib to prevent graft-versus-host disease.
Daily medication intake with regular monitoring visits during the first 35 days
Duration - Up to 1 year post-transplant
Participants are monitored for graft-versus-host disease and infection outcomes for up to 1 year after transplant.
Periodic visits for assessments over 1 year
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
D
Doris Ponce, MD, MS
B
Brian Shaffer, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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