RecruitingPhase 2NCT06846463

Zanubrutinib in Patients With DLBCL and MYD88 or NOTCH1 Mutation or CD5+

Phase 2 Trial Utilizing Zanubrutinib in Patients With Diffuse Large B-cell Lymphoma and MYD88 L265P Mutations, CD79B Mutations, NOTCH1 Truncation or Who Are CD5+ by IHC.

Sponsor

Virginia Commonwealth University

Enrollment

21 participants

Start Date

May 27, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma DLBCL - Diffuse Large B Cell Lymphoma

Summary

This study is a single-arm, open label, non-randomized, phase 2 trial of zanubrutinib in patients with diffuse large B-cell lymphoma (DLBCL) who have an MYD88 L265P mutation, a CD79B mutation, a NOTCH1 truncation, or who are CD5+ by immunohistochemistry (IHC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding zanubrutinib — a targeted drug that blocks a protein called BTK which helps certain lymphoma cells survive — to standard chemotherapy (R-CHOP) can improve outcomes in patients with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) that has specific genetic mutations. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of DLBCL - Your tumor has one of the following features: MYD88 L265P mutation, CD79B mutation, NOTCH1 mutation, or CD5+ status (lab tests your doctor can run) - You have started but have not yet completed your first cycle of R-CHOP chemotherapy - Your lymphoma is measurable on PET-CT scan **You may NOT be eligible if...** - You have completed more than one cycle of R-CHOP already - You have active bleeding or blood clotting problems - You have significant heart issues - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZanubrutinib

Investigational Agent Administration. Zanubrutinib will be first administered on Cycle 2 Day 1 of rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), vincristine sulfate (Oncovin), and prednisone (R-CHOP). It is up to the discretion of the treating physician how many cycles of R-CHOP the treatment would require, but it is not to exceed 6 cycles of R-CHOP and 5 cycles of zanubrutinib. The number of cycles of R-CHOP should be per standard of care, with the number of zanubrutinib cycles being 1 less than the number of total R-CHOP cycles.

Locations(1)

Virginia Commonwealth University

Richmond, Virginia, United States

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NCT06846463

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