drugset / Trial / NCT04978584

Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study

NCT04978584

Phase 2 Active not recruiting 62 enrolled M.D. Anderson Cancer Center
NaSequentialOpen-labelTreatment

Summary

This phase II trial studies the effect of rituximab, lenalidomide, acalabrutinib, tafasitamab alone and in combination with chemotherapy in treating patients with newly diagnosed non-germinal center diffuse large B-cell lymphoma. Rituximab and tafasitamab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. Acalabrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as lenalidomide, cyclophosphamide, doxorubicin, and vincristine, and work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving rituximab, lenalidomide, acalabrutinib, tafasitamab alone and with combination chemotherapy may help control non-germinal center diffuse large B-cell lymphoma.

Timeline

Start
2022-03-03
Primary completion
2027-01-16
Completion
2027-01-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule Oral
Subject Cyclophosphamide Other / unclassified Intravenous
Subject Doxorubicin Other / unclassified Intravenous
Subject Lenalidomide Other / unclassified Oral
Subject Prednisone Other / unclassified Oral
Subject Rituximab Monoclonal antibody Intravenous
Subject Tafasitamab Monoclonal antibody Intravenous
Subject Vincristine Small molecule Intravenous