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Kinase Inhibitor
Ibrutinib plus Ruxolitinib for Chronic B-Cell Leukemia
Phase 1 & 2
Waitlist Available
Led By David E Spaner, MD
Research Sponsored by Sunnybrook Health Sciences Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This study involves adding the kinase inhibitor Ruxolitinib to Ibrutinib to treat Chronic Lymphocytic Leukemia (CLL).
Eligible Conditions
- Chronic B-Cell Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
maximum tolerated dose (MTD) of ruxolitinib in combination with Ibrutinib.
Secondary outcome measures
ability of Ruxolitinib to increase the depth of response to Ibrutinib
Other outcome measures
effect of Ruxolitinib on levels of plasma cytokines and chemokines
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Ibrutinib plus RuxolitinibExperimental Treatment2 Interventions
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).
Group II: Ibrutinib aloneActive Control1 Intervention
Patients will continue to take Ibrutinib for the equivalent period of time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ruxolitinib
FDA approved
Ibrutinib
FDA approved
Find a Location
Who is running the clinical trial?
Sunnybrook Health Sciences CentreLead Sponsor
656 Previous Clinical Trials
1,551,401 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,999 Total Patients Enrolled
David E Spaner, MDPrincipal InvestigatorSunnybrook Odette Cancer Center
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