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Tyrosine Kinase Inhibitor
Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2
Waitlist Available
Research Sponsored by Calithera Biosciences, Inc
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 start of treatment to 21 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing mivavotinib, a medication for patients with a type of lymphoma that has returned or resisted treatment. It works by blocking specific changes in the cancer cells that help them grow.
Eligible Conditions
- MyD88 and CD79B Mutations
- Diffuse Large B-Cell Lymphoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ start of treatment to 21 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment to 21 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR) as assessed by an independent radiology review committee (IRC) according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
Safety as measured by type, incidence, severity, seriousness, and study drug-relatedness of adverse events per Common Terminology Criteria for Adverse Events, version 5
Secondary study objectives
Complete Response (CR) Rate as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
Duration of Response (DOR) Rate as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
Progression-Free Survival (PFS) as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Induction Dosing ScheduleExperimental Treatment1 Intervention
Mivavotinib 120 mg QD for 14 days, then 80 mg QD starting Day 15
Group II: Continuous Dosing ScheduleExperimental Treatment1 Intervention
Mivavotinib 100 mg once daily (QD)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mivavotinib
2019
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Calithera Biosciences, IncLead Sponsor
33 Previous Clinical Trials
2,019 Total Patients Enrolled