A Study to Evaluate the Efficacy of Venetoclax in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) Including Those With 17p Deletion or TP53 Mutation or Those Who Have Received a Prior B-cell Receptor Inhibitor.

Official Title

Open-Label, Single-Arm, Phase 3b, Multi-Centre Study Evaluating the Efficacy of Venetoclax (ABT-199) in Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL)


The purpose of this open-label, single-arm study is to evaluate the efficacy of venetoclax monotherapy in approximately 250 participants with relapsed/refractory CLL including those with the 17p deletion or TP53 mutation (assessed by local lab) OR those who have received prior treatment with a B-cell receptor inhibitor. The starting dose of venetoclax is 20 mg once daily. The dose must be gradually increased over a period of 5 weeks up to the daily dose of 400 mg. Participants may continue receiving venetoclax for up to 2 years. After the treatment period, participants may continue on into a 2-year follow-up period.

Trial Description

Primary Outcome:

  • Complete Remission Rate (CR + CRi) as assessed by the investigator
Secondary Outcome:
  • Time to Progression (TTP)
  • Overall Response Rate (ORR)
  • Duration of Overall Response (DoR)
  • CR Rate (CR + CRi)
  • Overall Survival (OS)
  • Progression-Free Survival (PFS)
  • Rate of Minimal Residual Disease (MRD)

View this trial on ClinicalTrials.gov

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Canadian Cancer Society

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