A Phase 2 interventional study of Mivavotinib in Non-GCB/ABC Diffuse Large B-Cell Lymphoma and With and Without MyD88 and/or CD79B Mutations, sponsored by Calithera Biosciences, Inc. Terminated at 7 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Calithera Biosciences, Inc · Phase 2, Interventional, and Treatment
Study CX-659-401 is a multicenter, open-label, phase 2 study of mivavotinib to evaluate the single-agent activity of mivavotinib in patients with relapsed/refractory non-GCB/ABC DLBCL, incorporating ctDNA-based next-generation sequencing (NGS) to identify DLBCL patients harboring MyD88 and/or CD79B mutations within the study. This goal of this strategy is to evaluate its activity both in the cell-of-origin subgroup of non-GCB/ABC DLBCL and in the genetically defined subgroups of MyD88/CD79B-mutated and wild type DLBCL.
Approximately 50 patients will be randomized 1:1 to one of two dose/schedule cohorts: one with a continuous dosing schedule (100 mg QD) and one with an induction dosing schedule (120 mg QD x 14 days, then 80 mg QD starting Day 15). Patients will receive treatment with mivavotinib until disease progression, unacceptable toxicity, withdrawal of consent, or death.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 2 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Calithera Biosciences, Inc is the lead sponsor of 29 studies on the registry; none are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 10 (59%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mivavotinib 100 mg once daily (QD)
Drug: Mivavotinib
Mivavotinib 120 mg QD for 14 days, then 80 mg QD starting Day 15
Drug: Mivavotinib
oral tablet
Also known as: CB-659
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).
Overall response is defined as a complete response (CR) or partial response (PR). ORR is the proportion of participants who have overall responses.
Time frame: Start of treatment up to 21 months
Safety as measured by type, incidence, severity, seriousness, and study drug-relatedness of adverse events per Common Terminology Criteria for Adverse Events, version 5
Type, incidence, severity, seriousness, and study drug-relatedness of AEs assessed by CTCAE v5.0
Time frame: Start of treatment up to 21 months
Duration of Response (DOR) Rate as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
DOR per IRC. DOR will be calculated as the time between the first documentation of partial response (PR) or a complete response (CR) to the first documentation of progressive disease or death, whichever occurs first.
Time frame: Start of treatment up to 21 months
Progression-Free Survival (PFS) as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
PFS per IRC. PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the IRC or death from any cause, whichever occurs first.
Time frame: Start of treatment up to 21 months
Complete Response (CR) Rate as assessed by an IRC according to the 2014 International Working Group (IWG) Lugano Criteria (Cheson, 2014).
CR rate per IRC according to the 2014 IWG Lugano criteria (Cheson, 2014)
Time frame: Start of treatment to 21 months
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Calithera Biosciences, Inc