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Clinical trial

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) (MURANO)

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Last updated:17th Mar 2014
Identifier: NCT02005471

The purpose of this open-label, multicenter, randomized, Phase III study is to evaluate the benefit of venetoclax in combination with rituximab compared with bendamustine in combination with rituximab in participants with relapsed or refractory CLL. Participants will be randomly assigned in 1:1 ratio to receive either venetoclax + rituximab (Arm A) or bendamustine + rituximab (Arm B).


Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 389 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase III, Open-Label, Randomized Study in Relapsed/Refractory Patients With Chronic Lymphocytic Leukemia to Evaluate the Benefit of Venetoclax (GDC-0199/ABT-199) Plus Rituximab Compared With Bendamustine Plus Rituximab
Actual Study Start Date: March 17, 2014
Actual Primary Completion Date: May 8, 2017
Estimated Study Completion Date: September 21, 2018

Arm:
- Active Comparator:
Bendamustine + Rituximab
- Experimental: Venetoclax + Rituximab

Category Value
Date last updated at source 2018-04-30
Study type(s) Interventional
Expected enrolment 389
Study start date 2014-03-17
Estimated primary completion date 2017-05-08

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