Study on Glofitamab with Rituximab and Chemotherapy for High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma

Sponsor: Hoffmann-La Roche

Sponsor score: 40

ClinicalTrials ID:NCT04980222

This clinical trial is testing a new treatment combination of glofitamab, rituximab, and chemotherapy drugs for patients with high-risk diffuse large B-cell lymphoma (DLBCL) who have not received any prior treatment.

Patient Parameters

Program Overview

The purpose of this Phase II study is to evaluate the safety and effectiveness of a new treatment combination for patients with high-risk diffuse large B-cell lymphoma (DLBCL). The treatment includes glofitamab, rituximab, and a chemotherapy regimen known as R-CHOP, which consists of cyclophosphamide, doxorubicin, vincristine, and prednisone. This study is for patients who have not been treated before and have a high level of circulating tumor DNA (ctDNA), which indicates a higher risk of cancer progression.

Eligibility Criteria

Inclusion Criteria

  • Patients who have not been treated before and have CD20-positive diffuse large B-cell lymphoma (DLBCL).
  • Includes specific types of DLBCL, such as those with certain genetic markers (MYC, BCL2, BCL6).
  • Patients with transformed follicular lymphoma may be eligible after consultation.
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must have a life expectancy of at least 6 months.
  • Must provide blood samples for biomarker testing before starting treatment.
  • Must have at least one measurable lymphoma lesion on a PET/CT scan.
  • Heart function must be adequate, with a left ventricular ejection fraction of 50% or higher.
  • Must have good blood cell production and function.
  • Must agree to use contraception during the study.
  • Additional requirement for high-risk participants: Must have a plasma sample showing high-risk ctDNA levels.

Exclusion Criteria

  • Patients with certain types of lymphoma, such as gray-zone lymphoma, primary mediastinal large B-cell lymphoma, and others.
  • Patients who cannot tolerate any components of the R-CHOP regimen due to allergies or previous reactions.
  • Patients who have received prior treatment for indolent lymphoma.
  • Patients who have had a solid organ or stem cell transplant.
  • Patients who have previously been treated for DLBCL or high-grade B-cell lymphoma, except for short-term steroid treatment.
  • Women who are pregnant, breastfeeding, or planning to become pregnant during the study or within a specified time after treatment.

Locations

FACILITYZIPCITYSTATE
City of Hope Comprehensive Cancer Center91010DuarteCalifornia
Stanford Cancer Center94305-5820StanfordCalifornia
University of Iowa52242Iowa CityIowa
Washington University; Wash Uni. Sch. Of Med63110St LouisMissouri
Memorial Sloan Kettering Bergen07645MontvaleNew Jersey
Memorial Sloan Kettering Cancer Center at Westchester10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Baylor University Medical Center75204DallasTexas

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