Randomized, Phase III Study of Early Intervention With Venetoclax and Obinutuzumab Versus Delayed Therapy With Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High Risk Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): EVOLVE CLL/SLL Study
- Sponsor:
- SWOG
- Sponsor Study ID:
- S1925
- CTO #:
- 103411
- NCT Number:
- NCT04269902
- Phase:
- III
- Protocol Type:
- Treatment
- Age Group:
- Adults
- Disease Sites:
- Lymphoid Leukemia
- Study Objectives:
- This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes 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. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.
- eConsent:
- Not available
- Study Documents:
-
Open Study Documents
(MUSC NetID required for document access)
For more information about this trial please contact the study team:
-
Medical University of South Carolina
- Affiliate Principal Investigator, Lupak, Oleksandra, at oll203@musc.edu .
- Principal Investigator, Hess, Brian, at hessbr@musc.edu .
- Study Coordinator, Mendiola, Hannah, at mendiola@musc.edu .
-
Ralph H. Johnson VAMC
- Study Coordinator, Jeter, Kathy, at katherine.jeter2@va.gov .
Trial opened at the following institutions:
Ralph H. Johnson VAMC, Medical University of South Carolina