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Clinical Trial Summary

A study of acalabrutinib plus venetoclax (AV) versus venetoclax plus obinutuzumab (VO) in previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma.

Clinical Trial Description

This is a phase III prospective, multicenter, randomized, open-label trial. After completion of the screening period, eligible participants will be randomized in a 1:1 ratio to each of the following intervention arms: Arm A: Minimal Residual Disease (MRD)-limited finite AV therapy Arm B: MRD-limited finite VO therapy The study consists of screening, treatment, and post-intervention follow-up periods. Participants will undergo safety and efficacy assessments during each period for each study arm. The duration of individual participant involvement in the study will be approximately 5 years. All participants who discontinue study intervention will be followed for safety assessments and survival status. Safety/survival follow-up is not required if the participant permanently discontinues study intervention due to withdrawal of consent, loss to follow-up, or death. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05057494
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Not yet recruiting
Phase Phase 3
Start date March 31, 2022
Completion date September 29, 2028