Study on Zanubrutinib for Patients with DLBCL and Specific Genetic Mutations or CD5+

Sponsor: Virginia Commonwealth University

Sponsor score: 0

ClinicalTrials ID:NCT06846463

Provider View

This clinical trial is testing the effects of adding the drug zanubrutinib to standard chemotherapy for patients with diffuse large B-cell lymphoma (DLBCL) who have certain genetic mutations or are CD5+.

Patient Parameters

Program Overview

The study aims to see if adding zanubrutinib to the usual chemotherapy can improve treatment outcomes for patients with DLBCL who have specific genetic mutations or are CD5+. The treatment will include zanubrutinib along with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Patients will be monitored through imaging tests, and some may have optional minimal residual disease (MRD) testing. The main goal is to see how many patients achieve a complete response, with a secondary goal of evaluating event-free survival at 2 years. Patients will be followed every 3 months for 2 years after treatment, with extended follow-up for up to 5 years.

Description

This study is designed to evaluate the effects of adding zanubrutinib to the standard chemotherapy regimen for patients with diffuse large B-cell lymphoma (DLBCL) who have specific genetic mutations or are CD5+. The treatment involves combining zanubrutinib with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Patients will start zanubrutinib on the second cycle of R-CHOP, with a maximum of 6 cycles of R-CHOP and 5 cycles of zanubrutinib. The number of R-CHOP cycles will be determined by the treating physician, but zanubrutinib cycles will be one less than the total R-CHOP cycles. Patients will be monitored with standard imaging tests, and optional minimal residual disease (MRD) testing may be conducted. The primary goal is to assess the complete response rate, while the secondary goal is to evaluate event-free survival at 2 years. Patients will be followed every 3 months for 2 years after treatment, with an extended follow-up period of up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL).
  • Must have specific genetic mutations (MYD88 L265P, CD79B, NOTCH1 truncation) or be CD5+.
  • Must be 18 years or older.
  • Must have measurable disease on a CT/PET scan.
  • Must not have received more than one cycle of R-CHOP before joining the study.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have adequate bone marrow and organ function based on specific blood test results.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during and after treatment.
  • Must not have allergies or intolerances to study medications.
  • Must be able to provide informed consent and agree to follow study requirements.

Exclusion Criteria

  • Patients with high-grade B-cell lymphoma with certain genetic rearrangements.
  • Patients with cancer that has spread to the brain.
  • Patients with severe nerve damage.
  • Patients with significant heart disease or recent heart attack.
  • Patients with other cancers within the past 3 years, except for certain skin or localized cancers.
  • Patients with severe bleeding disorders.
  • Patients with recent stroke or brain bleeding.
  • Patients with severe lung disease.
  • Patients unable to swallow capsules or with severe digestive issues.
  • Patients with active infections requiring treatment.
  • Patients with certain viral infections like active hepatitis B or C, or HIV.
  • Patients who have had major surgery recently.
  • Pregnant or breastfeeding women.
  • Patients with low heart function.
  • Patients who have received a live vaccine recently.
  • Patients allergic to study drugs.
  • Patients on certain medications that interact with the study drug.
  • Patients in another clinical trial.
  • Patients with active autoimmune blood disorders.
  • Patients on blood thinners like warfarin.

Locations

FACILITYZIPCITYSTATE
Virginia Commonwealth University23298RichmondVirginia

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