Study on Glofitamab with Rituximab and Chemotherapy for High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma
Sponsor: Hoffmann-La Roche
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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Stanford Cancer Center | 94305-5820 | Stanford | California |
| University of Iowa | 52242 | Iowa City | Iowa |
| Washington University; Wash Uni. Sch. Of Med | 63110 | St Louis | Missouri |
| Memorial Sloan Kettering Bergen | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Cancer Center at Westchester | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Baylor University Medical Center | 75204 | Dallas | Texas |
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