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
This trial does not accept healthy volunteersQualifiers
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. 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Ruxolitinib
DrugRuxolitinib is a Janus kinase inhibitor.
Prednisone
DrugPrednisone is a glucocorticoid.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Ruxolitinib Treatment ArmExperimental treatment 1 intervention
Group B: Prednisone Treatment ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Success
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.
Time frame
6 monthsSecondary outcomes
1
Treatment Success Rate
The proportion of subjects who are alive with NIH CR/PR, no new systemic therapy for cGVHD, and \< 0.25 mg/kg/day prednisone at C7D1 with 95% CI for each arm will be estimated.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Incyte Corporation
Collaborator
Source ClinicalTrials.gov