TerminatedPhase 2

Study of Mivavotinib (CB-659) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Stopped: Sponsor Decision

United States2 participantsStarted 2022-06-23

Plain-language summary

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.

Who can participate

Age range18 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients aged 18 years or older
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
✓. Life expectancy of \> 3 months
✓. Histologically confirmed de novo or transformed non-GCB DLBCL.
✓. Relapsed or refractory to ≥ 2 prior lines of chemotherapy based on standard of care
✓. Patients should not have failed more than 5 prior lines of therapy
✓. Must have \[18F\]Fluorodeoxyglucose-positron emission tomography (FDG-PET)-avid measurable disease that meets the size criteria per International Working Group (IWG) criteria.
✓. Must have recovered from adverse events of prior anti-cancer therapy to severity ≤ Grade 1.

Exclusion criteria

✕. DLBCL with central nervous system (CNS) involvement with active brain or leptomeningeal disease

What they're measuring

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).

Timeframe: 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

Timeframe: Start of treatment up to 21 months

Trial details

NCT IDNCT05319028

SponsorCalithera Biosciences, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-24

View on ClinicalTrials.gov More Non-GCB/ABC Diffuse Large B-Cell Lymphoma trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female patients aged 18 years or older
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
✓. Life expectancy of \> 3 months
✓. Histologically confirmed de novo or transformed non-GCB DLBCL.
✓. Relapsed or refractory to ≥ 2 prior lines of chemotherapy based on standard of care
✓. Patients should not have failed more than 5 prior lines of therapy
✓. Must have \[18F\]Fluorodeoxyglucose-positron emission tomography (FDG-PET)-avid measurable disease that meets the size criteria per International Working Group (IWG) criteria.
✓. Must have recovered from adverse events of prior anti-cancer therapy to severity ≤ Grade 1.

Exclusion criteria

✕. DLBCL with central nervous system (CNS) involvement with active brain or leptomeningeal disease

What they're measuring

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).

Timeframe: 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

Timeframe: Start of treatment up to 21 months