Comparing Ruxolitinib and Prednisone for treating chronic GVHD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial aims to evaluate the effectiveness of Ruxolitinib compared to Prednisone as a first-line treatment for patients with chronic graft-versus-host disease (cGVHD) requiring systemic therapy. The study will enroll adults diagnosed with cGVHD who have not received any new immunosuppressive therapy in the two weeks prior to enrollment. Participants will be randomly assigned to receive either Ruxolitinib or Prednisone, with the goal of determining which treatment offers better outcomes in managing this condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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:

  1. absolute neutrophil count ≥1,000/mcL
  2. platelets ≥30,000/mcL
  3. Hemoglobin ≥ 7 g/dL
  4. Bilirubin ≤ 3 times institutional upper limit of normal (ULN) unless attributable to GVH

  d. AST(SGOT)/ALT(SGPT) ≤5 × institutional ULN unless attributable to GVH e. creatinine clearance ≥30 ml/min
* 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 Criteria:

* 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.

Where it's running

• Univ of Miami - Sylvester Comprehensive Cancer Center
  Miami, Florida, United States Recruiting
• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• University of Kansas Cancer Center
  Kansas City, Kansas, United States Recruiting
• Fox Chase Cancer Center
  Philadelphia, Pennsylvania, United States Recruiting
• University of Virginia Comprehensive Cancer Center
  Charlottesville, Virginia, United States Recruiting
• Virginia Commonwealth University
  Richmond, Virginia, United States Recruiting

Study contacts

• Principal investigator: Farhad Khimani, MD — Moffitt Cancer Center
• Study coordinator: Sarah Starr
• Email: Sarah.Starr@moffitt.org
• Phone: 813-745-2690

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Testing WJ01024 Alone and with Ruxolitinib for Myelofibrosis with Splenomegaly

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• Belumosudil vs. Ruxolitinib for hepatic cGVHD after HSCT

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• Topical ruxolitinib for adults with pyoderma gangrenosum

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.