Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
NCT03681561 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2026-03-09
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).
Conditions
Interventions
- DRUG
-
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.
- DRUG
-
Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years
Sponsors & Collaborators
- collaborator INDUSTRY
- collaborator INDUSTRY
-
Veronika Bachanova
lead OTHER
Principal Investigators
-
Veronkia Bachanova · University of Minnesota
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-13
- Primary Completion
- 2026-03-31
- Completion
- 2027-07-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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