drugset / Trial / NCT04169737

Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

NCT04169737

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth cancer cells by blocking BCL-2 protein needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and venetoclax together with early obinutuzumab may improve clinical outcomes and control the disease.

Timeline

Start
2020-07-29
Primary completion
2028-07-09
Completion
2028-07-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Acalabrutinib Small molecule Oral
Subject Obinutuzumab Monoclonal antibody Intravenous
Subject Venetoclax Small molecule Oral