Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Veronika Bachanova
Study ID
NCT03681561
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib — DRUG
    Phase I: Ruxolitinib at assigned dose\* twice daily by mouth begin Day 1 and continuing daily until study treatment stop. * Dose Levels: 1. (starting) : 10mg twice daily 2: 15mg twice daily 3: 20mg: twice daily Phase II: Ruxolitinib 20mg twice daily by mouth begin Day 1 and continuing daily until study treatment stop.
  • Nivolumab — DRUG
    Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years

Study Details

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).

Key Dates

Start date
Sep 13, 2018
Status verified
Jun 2026
Primary completion
Sep 30, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
54 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I:Ruxolitinib and Nivolumab
    Participants will receive ruxolitinib at their assigned dose taken orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.
  • Experimental: Phase II: Ruxolitinib and Nivolumab
    Participants will receive ruxolitinib at 20mg orally twice daily on a 28-day cycle combined with nivolumab 480 mg IV administered every 4 weeks (i.e. on Day 1 of a 28-day cycle) until disease progression, unacceptable toxicity, or for a maximum of 2 years.

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: 24 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612-
Indiana Melvin and Bren Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of MinnesotaMinneapolisMinnesota55455
Veronika Bachanova, MD
[email protected]
612-625-5469
Veronika Bachanova, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Protocol Implementation Coordinator
[email protected]
614-293-3717
Timothy Voorhees, MD (PRINCIPAL_INVESTIGATOR)
University of WisconsinMadisonWisconsin53705
Kaitlin Chambers
[email protected]
608-263-5006
Vaishalee Kenkre, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By research site
University of Illinois Cancer Center· Chicago, ILIndiana Melvin and Bren Simon Comprehensive Cancer Center· Indianapolis, INUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Minnesota· Minneapolis, MNOhio State University Comprehensive Cancer Center· Columbus, OHUniversity of Wisconsin· Madison, WI

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