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Kinase Inhibitor
Pembrolizumab for Chronic Lymphocytic Leukemia
Phase 2
Waitlist Available
Led By Julio Chavez, M.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have high risk CLL
Have documented previously untreated CLL according to IWCLL criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial will study the effect of combining two drugs, pembrolizumab/MK-1375 and ibrutinib, on patients with high-risk chronic lymphocytic leukemia who have not been treated before. Researchers will look at how well the drugs work and how they affect the patients' immune system.
Eligible Conditions
- Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) to the Therapeutic Intervention
Time to Best Response
Secondary outcome measures
Progression-free Survival (PFS)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab and IbrutinibExperimental Treatment2 Interventions
Treatment with pembrolizumab and ibrutinib and follow-up period of up to 24 months.
Pembrolizumab is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
Ibrutinib is an inhibitor of Bruton's tyrosine kinase (BTK). Ibrutinib is a small-molecule inhibitor of BTK.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Ibrutinib
2014
Completed Phase 3
~1880
Find a Location
Who is running the clinical trial?
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
537 Previous Clinical Trials
134,986 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,695 Total Patients Enrolled
Janssen Scientific Affairs, LLCIndustry Sponsor
157 Previous Clinical Trials
579,667 Total Patients Enrolled
Frequently Asked Questions
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