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

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT06846463
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanubrutinib — DRUG
    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.

Study Details

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).

Key Dates

Start date
May 27, 2025
Status verified
Jan 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2032

Study Design

Enrollment
21 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Agent Administration
    Zanubrutinib is administered as capsules for oral intake at one of the following dosages based on the discretion of the treating physician: * 160 mg (two 80-mg capsules) twice daily * 320 mg (four 80-mg capsules) once daily

Primary Outcome Measure

Assess efficacy of adding oral zanubrutinib to R-CHOP in patients with DLBCL who have an MYD88 L265P mutation, a CD79B mutation, a NOTCH1 truncation, or who are CD5+ by Immunohistochemistry (IHC) in achieving complete response defined by Lugano criteria [ Time Frame: Completion of treatment through 2 years +/- 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Massey Heme Malig Team
[email protected]
804-628-6430
Bruce Hough, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Virginia Commonwealth University· Richmond, VA

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