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Clinical trial

Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

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Last updated:19th Mar 2020
Identifier: NCT04075292

Brief Summary:
This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.

Detailed Description:
Patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (Arm A) or rituximab in combination with chlorambucil (Arm B). The primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or TP53 mutation.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Acalabrutinib Versus Chlorambucil Plus Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia
Estimated Study Start Date: March 19, 2020
Estimated Primary Completion Date: February 28, 2023
Estimated Study Completion Date: February 28, 2023

Arms:
- Experimental:
Acalabrutinib
- Active Comparator: Rituximab and Chlorambucil

Category Value
Date last updated at source 2019-08-30
Study type(s) Interventional
Expected enrolment 150
Study start date 2020-03-19
Estimated primary completion date 2023-02-28

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