Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma
ConditionHodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeronika Bachanova
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ruxolitinib
- Nivolumab
Treatment groups
54 Participants
are divided into 2 treatment groupsSponsors and collaborators
Veronika Bachanova
Lead sponsor
Big Ten Cancer Research Consortium
Sponsor institution
Incyte Corporation
Collaborator
Bristol-Myers Squibb
Collaborator
Source ClinicalTrials.gov