Recruiting
Phase 2

Venetoclax & Obinutuzumab

Sponsor:

AbbVie

Code:

NCT04895436

Conditions

Chronic Lymphocytic Leukemia (CLL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Venetoclax

Obinutuzumab

Study Details

Brief summary:

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). 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 cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X 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.

Conditions

Chronic Lymphocytic Leukemia (CLL)

Study ID

NCT04895436

Start date

Mar 28, 2022

Status verified date

Feb, 2026

Completion date

Jan, 2029

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1 - venetoclax + obinutuzumab

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.

experimental: Cohort 2 - venetoclax + obinutuzumab

Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.

Interventions

Venetoclax

Oral tablet

Obinutuzumab

Intravenous (IV) infusion

Primary outcome measure

  • Overall response (OR) in Cohort 1 after end of combination treatment [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Locations

Moores Cancer Center at UC San Diego /ID# 230157

Recruiting

La Jolla, California, United States, 92093

Winship Cancer Institute of Emory University /ID# 230643

Recruiting

Atlanta, Georgia, United States, 30322

Dana-Farber Cancer Institute /ID# 230061

Recruiting

Boston, Massachusetts, United States, 02215

St. Lukes Hospital of Duluth /ID# 250021

Recruiting

Duluth, Minnesota, United States, 55805

Hattiesburg Clinic /ID# 233443

Recruiting

Hattiesburg, Mississippi, United States, 39401

Regional Cancer Care Associates /ID# 244620

Recruiting

Hackensack, New Jersey, United States, 07601-7015

University of North Carolina /ID# 233313

Recruiting

Chapel Hill, North Carolina, United States, 27514

Novant Health Presbyterian Medical Center /ID# 230201

Recruiting

Charlotte, North Carolina, United States, 28204

Novant Health Forsyth Medical Center /ID# 249533

Recruiting

Winston-Salem, North Carolina, United States, 27103

The Ohio State University /ID# 230439

Recruiting

Columbus, Ohio, United States, 43210

Pennsylvania Oncology Hematolo /ID# 249637

Recruiting

Philadelphia, Pennsylvania, United States, 19106

More Information

Sponsor

AbbVie

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • Chronic Lymphocytic Leukemia (CLL)
  • Venetoclax
  • ABT-199
  • Venclexta
  • GDC-0199
  • Obinutuzumab
  • Gazyva
  • GA101
  • Cancer
  • ReVenG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-02-09.