Nivolumab With Ruxolitinib for Relapsed or Refractory Classical Hodgkin Lymphoma
This study is testing a combination of two drugs, nivolumab and ruxolitinib, for people with classical Hodgkin lymphoma (a type of cancer) that has come back or not responded to previous treatments. The study aims to find the highest safe dose of ruxolitinib when given with nivolumab, and to see how well this combination controls the disease. You may be able to join if you are at least 18 years old and have a good general health status (ECOG Performance Status of 0, 1 or 2). The study will look at the maximum tolerated dose and overall disease control over 24 months. The current recruitment status is unclear, and the study plans to enroll 54 participants.
- Study design
- This is a Phase I/II, multi-center study where all participants know what treatment they are receiving. It will involve increasing doses of ruxolitinib with a fixed dose of nivolumab.
- What's involved
- You would take ruxolitinib by mouth twice daily and receive nivolumab intravenously (IV) every 4 weeks. Treatment continues until the disease gets worse, side effects are too severe, you choose to stop, or for a maximum of 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures maximum tolerated dose and overall disease control at 24 months.
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NCT03681561
Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
Recruiting
PHASE1Ages 18+InterventionalTreatmentVeronika BachanovaInvestigator-initiated
~54 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:RuxolitinibNivolumab
At a glance
Recruiting sites
3 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum Tolerated Dose
Measured over 24 months
+1 more outcome measured
Conditions
Where it's being run
6 sites across 6 statesIllinois1
Indiana1
Iowa1
Minnesota1
Ohio1
Wisconsin1
Study leadership
- Veronkia Bachanova, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 not required for Phase II.
Presence of radiographically measurable disease (defined as the presence one or more ≥ 1.5 cm lesions, as measured in the longest dimension by PET/CT) within 4 weeks of study registration.
Prior therapy with check-point inhibitors (nivolumab, pembrolizumab, others) and subsequent progressive disease, stable disease, mixed response, or relapse
Failed at least one prior therapy
Prior cancer treatment must be completed at least 14 days prior to registration and the patient must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline. Radiation therapy must be completed at least 7 days prior to registration.
Absolute Neutrophil Count ≥ 1000/μL
Platelets ≥ 75,000/μL (or ≥50,000/mm3 if known BM involvement)
Calculated creatinine clearance ≥ 40 cc/min using the Cockcroft-Gault formula
Bilirubin ≤ 1.5 x upper limit of normal (ULN)
Aspartate aminotransferase (AST) ≤ 2.5 × ULN
Alanine aminotransferase (ALT) ≤ 2.5 × ULN
Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months
Males who are sexually active with partners of child-bearing potential must be willing to abstain from heterosexual activity or adhere to contraception from the time of written consent until 7 months after treatment discontinuation.
Patient must provide voluntary written informed consent prior to the performance of any research related tests or procedures.
Exclusion
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 ≤ 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.
History of stroke or intracranial hemorrhage within 6 months of study registration
What this trial measures
- Maximum Tolerated Dose24 months
To assess the maximum tolerated dose (MTD) of ruxolitinib in combination with nivolumab in patients with relapsed/refractory Hodgkin lymphoma. (Phase I Only)
- Overall Disease Control24 months
To evaluate the best Overall Disease Control (CR+PR+SD) at 3 months of nivolumab in combination with ruxolitinib at MTD in patients with relapsed/refractory Hodgkin lymphoma using the modified Lugano Classification "lymphoma response criteria to immunomodulatory therapy criteria" (LYRIC)1 (Phase II Only)