Actively Recruiting
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Led by Veronika Bachanova · Updated on 2026-03-09
54
Participants Needed
6
Research Sites
459 weeks
Total Duration
On this page
Sponsors
V
Veronika Bachanova
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written informed consent and HIPAA authorization
- Age 18 years or older at consent
- ECOG Performance Status of 0, 1, or 2
- Histologically confirmed classical Hodgkin lymphoma that is relapsed or refractory
- Presence of measurable disease with one or more lesions 1.5 cm or larger by PET/CT within 4 weeks of registration
- Prior therapy with checkpoint inhibitors and documented disease progression, stable disease, mixed response, or relapse
- Failed at least one prior therapy
- Completed prior cancer treatment at least 14 days before registration and recovered from acute toxic effects to Grade 1 or baseline (except alopecia)
- Completed radiation therapy at least 7 days before registration
- Absolute Neutrophil Count of 1000/µL or higher
- Platelet count of 75,000/µL or higher (or 50,000/µL if bone marrow involvement is known)
- Calculated creatinine clearance of 40 cc/min or higher
- Bilirubin less than or equal to 1.5 times the upper limit of normal
- AST and ALT less than or equal to 2.5 times the upper limit of normal
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration
- Males sexually active with partners of childbearing potential must agree to abstain or use contraception from consent until 7 months after treatment stops
- Provide voluntary written informed consent before any research tests or procedures
You will not qualify if you...
- Pregnant or breastfeeding
- Unable or unwilling to swallow oral medication or have conditions preventing oral drug absorption
- Life-threatening illness, medical condition, or organ dysfunction that could compromise safety or study outcomes
- Active central nervous system involvement by lymphoma
- Uncontrolled cardiovascular disease including symptomatic arrhythmias, congestive heart failure, recent myocardial infarction, or Class 3 or 4 cardiac disease
- Use of immunosuppressive agents except low-dose corticosteroids (≤10 mg/day prednisone or equivalent)
- History of autoimmune diseases within past 3 years except certain stable conditions like vitiligo, alopecia, treated hypothyroidism, or psoriasis not requiring systemic treatment
- Active Hepatitis B or C infection
- Clinically significant hepatic impairment Child-Pugh class B or C
- Currently taking strong CYP3A4 inhibitors or fluconazole >200 mg/day without a 1-week washout
- History of stroke or intracranial hemorrhage within 6 months prior to registration
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Completed
2
Indiana Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Withdrawn
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Active, Not Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
6
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
V
Veronika Bachanova
CONTACT
A
Ahran Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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