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Ruxolitinib vs. Prednisone for Chronic Graft-versus-host Disease (cGVHD)

This study is looking at two different medicines, Ruxolitinib and Prednisone, as the first treatment for chronic Graft-versus-host Disease (cGVHD). cGVHD is a complication that can happen after a stem cell transplant. Ruxolitinib is a drug that has already been approved for cGVHD when other treatments haven't worked. This study wants to see if Ruxolitinib works better than Prednisone as a very first treatment. You might be able to join if you are 18 or older, have cGVHD that needs treatment, and are generally well enough to participate. The study will measure how successful the treatment is after 6 months. The current recruitment status is unclear.

Study design
This is a randomized study that will compare Ruxolitinib to Prednisone. It plans to include 120 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Treatment success will be measured at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06660355

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~120 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:RuxolitinibPrednisone

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Success
Measured over 6 months

Conditions

Chronic Graft-versus-host Disease (cGVHD)

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Chronic Graft Versus Host Disease

NCT06660355

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

  • Moffitt Cancer Center

    Tampa, Floridano site contact published

    Recruiting

  • Univ of Miami - Sylvester Comprehensive Cancer Center

    Miami, Floridano site contact published

    Recruiting

  • University of Kansas Cancer Center

    Kansas City, Kansasno site contact published

    Recruiting

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginiano site contact published

    Recruiting

  • Virginia Commonwealth University

    Richmond, Virginiano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Farhad Khimani, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Sarah Starr
[email protected]
813-745-2690
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Age ≥ 18 years.
Karnofsky performance status ≥60%.
Patients with a diagnosis of chronic GVHD per NIH diagnostic criteria5 who are in need for first systemic therapy as per treating physician's discretion, Overlap chronic GVHD will be allowed.
No new immune suppressive therapy added within preceding 2 weeks prior to study enrolment.
Able to take oral medications.
Participants must have adequate organ and marrow function as defined below:
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.
Ability to understand and the willingness to sign a written informed consent document.

Exclusion

Previously treated with systemic immune suppressive therapy for chronic GVHD (where the indication for start of that systemic immune suppressive therapy was chronic GVHD).
Patients with clinically significant or uncontrolled cardiovascular disease, including unstable angina, acute myocardial infarction, or stroke within 6 months, New York Heart Association class III or IV heart failure will be excluded.
Relapse malignancy post- transplant. Molecular relapse or Mixed chimerism or treated relapse in remission may be allowed on case by case basis but needs discussion with the study Chair/PI
Active hepatitis B, hepatitis C and HIV will be excluded.
Any uncontrolled infection at the time if enrollment will be excluded.
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Ruxolitinib.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women and lactating women are excluded from this study because of the potential for teratogenic or abortifacient effects and an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Ruxolitinib, breastfeeding should be discontinued if the mother is treated with Ruxolitinib.
Current or history of active Tuberculosis.

What this trial measures

  • Treatment Success6 months

    Treatment Success is defined as C7D1 NIH CR/PR without death or new line of immune suppressive therapy and will be estimated for both arms.