Phase I/II Study of Nivolumab in Combination With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Veronika Bachanova
Summary
This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. * Age ≥ 18 years at the time of consent. * ECOG Performance Status of 0, 1 or 2. * Histologically confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or refractory - historical biopsy at last relapse is acceptable. NOTE: a repeat biopsy is not required for Phase I if the historical biopsy was performed at the most recent relapse, without remission in between. A fresh biopsy is…
Interventions
- DrugRuxolitinib
Phase I: Ruxolitinib at assigned dose\* twice daily by mouth begin Day 1 and continuing daily until study treatment stop. * Dose Levels: 1. (starting) : 10mg twice daily 2: 15mg twice daily 3: 20mg: twice daily Phase II: Ruxolitinib 20mg twice daily by mouth begin Day 1 and continuing daily until study treatment stop.
- DrugNivolumab
Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years
Locations (6)
- University of Illinois Cancer CenterChicago, Illinois
- Indiana Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- University of MinnesotaMinneapolis, Minnesota
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- University of WisconsinMadison, Wisconsin