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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

Allogeneic transplant is potentially curative for hematological malignancies but its use is limited by the development of GVHD. Ruxolitinib now has FDA approval for treatment of chronic GVHD that has failed 1-2 prior lines of therapy based on a prior large, randomized phase III study. Given this evidence of safety and efficacy in the early refractory setting (after prednisone failure), Ruxolitinib represents an ideal agent to test in the primary therapy setting. Here investigators propose a phase 2 randomized study to compare Ruxolitinib to prednisone as a first-line therapy in the treatment of chronic GVHD.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Active hepatitis B, hepatitis C and HIV will be excluded.

Trial design

Treatments tested in this trial

  • Ruxolitinib
  • Prednisone

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators