Two-Drug cocktail targets Hard-to-Treat hodgkin lymphoma
NCT ID NCT03681561
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests two drugs—nivolumab and ruxolitinib—together in people whose Hodgkin lymphoma has returned or not responded to treatment. The goal is to find the safest dose of ruxolitinib when combined with a fixed dose of nivolumab, and to see if the combination can control the cancer for at least 3 months. About 54 adults will take part in this early-phase trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab (Opdivo) and ruxolitinib (Jakafi)
- What this could lead to
- If successful, this combination could offer a new treatment option for people with Hodgkin lymphoma that has not responded to standard therapies.
- What could go wrong
- This is an early-phase trial with only 54 participants, so results may not apply to everyone. The combination may cause significant side effects or fail to control the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2018
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 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 ≤ 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Indiana Melvin and Bren Simon Comprehensive Cancer Center
WITHDRAWNIndianapolis, Indiana, 46202, United States
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Ohio State University Comprehensive Cancer Center
RECRUITINGColumbus, Ohio, 43210, United States
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University of Illinois Cancer Center
COMPLETEDChicago, Illinois, 60612, United States
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University of Iowa Hospitals and Clinics
ACTIVE_NOT_RECRUITINGIowa City, Iowa, 52242, United States
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Wisconsin
RECRUITINGMadison, Wisconsin, 53705, United States
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