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RecruitingLast updated: 8 February 2024

ReVenG: This study is assessing the effectiveness of re-treatment with a combination of targeted therapy drugs in people with recurring chronic lymphocytic leukaemia who have previously had treatmentA Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

Clinical summary

Summary

This study is recruiting people with chronic lymphocytic leukaemia who have had prior treatment with venetoclax targeted therapy in combination with an anti-CD20 antibody, with or without another therapy. Eligible participants must have achieved a document response to their first-line therapy treatment to be eligible. Participants will be assigned to one of two experimental cohorts. Participants in both cohorts will receive combination targeted therapy that consists of intravenous (IV) obinutuzumab plus oral venetoclax (VenG). This will be given in 28-day cycles for a total of 6 cycles per cohort. Following this, all participants will receive venetoclax alone. Those in Cohort 1 will receive 6 cycles of venetoclax alone. Those in Cohort 2 will receive 18 cycles of venetoclax alone.

Conditions

This trial is treating patients with chronic lymphocytic leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

ReVenG

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Trial Identifiers

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Trial sponsor

AbbVie

Scientific Title

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

Eligibility

Inclusion

  • Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
  • Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
  • More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.

Exclusion

- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.
  • You have had treatment, but your cancer has come back.

Exclusion

  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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