ποΈ Verified NIH Record β’ Updated 2026-06-10
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma (NCT03681561)
π’ Recruiting Phase1 / Phase2 π Investigational Drug / Biologic Sponsor: Veronika Bachanova
π©Ί Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (17 items) and avoid the listed exclusions (13 items).
Location: University of Illinois Cancer Center β Chicago, Illinois
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- Inability or unwillingness to swallow oral medication or any condition that precludes the administration and/or absorption of oral medications
- A life-threatening illness, medical condition or organ system dysfunction, which in the investigator's opinion, could compromise the patient's safety, interfere with the metabolism of study drugs, or put the study outcomes at undue risk
- Active central nervous system (CNS) involvement by lymphoma
- Uncontrolled cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Concomitant therapy with immunosuppressive agents, including systemic corticosteroids (doses β€ 10 mg/day prednisone or equivalent are permitted).
- Has a history of autoimmune disease now or in past 3 years such as hepatitis, nephritis, hyperthyroidism, interstitial lung disease or colitis except vitiligo or alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.
- Active Hepatitis B or C infection (defined as a positive Hepatitis B surface antigen (Ag) or detectable viral load by PCR). NOTES: Hepatitis B and C testing is required. Patients with positive Hepatitis B Ag may enroll if PCR is negative. Suppressive antiviral therapy should be considered for these patients as clinically indicated.
- Currently active, clinically significant hepatic impairment Child-Pugh class B or C
- Currently receiving a strong CYP3A4 Inhibitor (such as but not limited to boceprevir clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) or Fluconazole \>200 mg/day. Washout period of 1 week is required.
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (6 Sites)
- University of Illinois Cancer Center β Chicago, Illinois
- Indiana Melvin and Bren Simon Comprehensive Cancer Center β Indianapolis, Indiana
- University of Iowa Hospitals and Clinics β Iowa City, Iowa
- University of Minnesota β Minneapolis, Minnesota
- Ohio State University Comprehensive Cancer Center β Columbus, Ohio
- University of Wisconsin β Madison, Wisconsin
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.