A Phase III Study of Acalabrutinib plus R-CHOP Therapy in Patients 65 and Younger with Previously Untreated Diffuse Large B-Cell Lymphoma

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Full Title

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Acalabrutinib in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects </=65 Years with Previously Untreated Non-Germinal Center Diffuse Large B-Cell Lymphoma (ACE-LY-312) (WIRB)

Purpose

R-CHOP, a combination of the chemotherapy drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, is a standard treatment for diffuse large B-cell lymphoma (DLBCL). In this study, researchers want to see if adding the medication acalabrutinib can make treatment more effective in adults age 65 and younger with previously untreated “non-germinal center” DLBCL.

Acalabrutinib is an approved drug for the treatment of adults with another type of non-Hodgkin lymphoma called mantle cell lymphoma and for a type of leukemia called chronic lymphocytic leukemia. Its use in this study is considered investigational. Acalabrutinib inhibits an enzyme called BTK that promotes DLBCL growth. All patients will receive standard R-CHOP chemotherapy and will be randomly assigned to also receive either acalabrutinib or a placebo.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be newly diagnosed with non-germinal center DLBCL.
  • Patients may not have received prior treatment for their cancer.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients ages 18-65.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew Matasar at 212-639-8889.

Protocol

21-141

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators