A Phase II Study of Glofitamab Immunotherapy plus R-CHOP for People with Diffuse Large B-Cell Lymphoma

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Full Title

A Phase II Study Evaluating the Safety and Efficacy of Glofitamab in Combination with Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma

Purpose

The purpose of this study is to assess the safety and effectiveness of adding glofitamab immunotherapy to standard R-CHOP chemotherapy in people with previously untreated diffuse large B-cell lymphoma (DLBCL) who have high levels of circulating tumor DNA (ctDNA) in their bloodstream. A high level of ctDNA may signal that the person will be less likely to have a complete response to standard treatments and that their lymphoma may be more likely to grow back.

Glofitamab boosts the power of the immune system to detect and destroy cancer cells. R-CHOP consists of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. The medications used in this study are given intravenously (by vein), except for prednisone, which is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have DLBCL that has not yet been treated and contains the CD20 protein.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Lorenzo Falchi at 646-608-3705.

Protocol

22-290

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators