Ruxolitinib Combined With Ibrutinib in Chronic Lymphocytic Leukemia Patients

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT02912754
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell

Eligibility Criteria

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

Interventions

  • ruxolitinib — DRUG
    ruxolitinib will be added to ibrutinib or 3 out of 5 weeks per cycle
  • ibrutinib — DRUG
    patients will be taking ibrutinib for at least 6 months and will continue to take it at the same dose and schedule while taking ruxolitinib

Study Details

This study involves adding the kinase inhibitor Ruxolitinib to Ibrutinib to treat Chronic Lymphocytic Leukemia (CLL).

Key Dates

Start date
Mar 31, 2017
Status verified
Sep 2016
Primary completion
Dec 31, 2018
Completion
Aug 31, 2019

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib plus Ruxolitinib
    Patients taking ibrutinib for relapsed CLL will add ruxolitinib twice per day at the dose identified in a preliminary phase I trial for 7 cycles (3 weeks on/2 weeks off).
  • No Intervention: Ibrutinib alone
    Patients will continue to take Ibrutinib for the equivalent period of time.

Primary Outcome Measure

maximum tolerated dose (MTD) of ruxolitinib in combination with Ibrutinib. [ Time Frame: 2 years ]

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