Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion

Description

Summary

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess how well venetoclax + obinutuzumab (VenG) works and how safe they are in adult participants with CLL who were previously treated with VenG. Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called treatment arms, based on when symptoms of CLL came back after previous treatment with VenG. Approximately 75 adult participants with CLL who have been treated with VenG will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official 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

Keywords

Chronic Lymphocytic Leukemia (CLL) Venetoclax ABT-199 Venclexta GDC-0199 Obinutuzumab GA101 Cancer ReVenG Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell venetoclax + obinutuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 + obinutuzumab (VenG) 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 VenG treatment.

You CAN'T join if...

  • Received intervening treatment for CLL after previous treatment with VenG.

Locations

  • Moores Cancer Center at UC San Diego /ID# 230157 accepting new patients
    La Jolla California 92093 United States
  • Des Moines Oncology Research Association /ID# 232606 accepting new patients
    Des Moines Iowa 50309-1423 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
Related info
ID
NCT04895436
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 75 study participants
Last Updated