Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL) (ReVenG)

February 5, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital /ID# 229898
    • Victoria
      • Epping, Victoria, Australia, 3076
        • Recruiting
        • Northern Hospital Epping /ID# 229847
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter MacCallum Cancer Ctr /ID# 254634
  • Austria
      • Salzburg, Austria, 5020
        • Completed
        • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
      • Vienna, Austria, 1140
        • Recruiting
        • Hanusch Krankenhaus /ID# 230010
    • Lower Austria
      • Sankt Pölten, Lower Austria, Austria, 3100
        • Recruiting
        • Universitaetsklinikum St. Poelten /ID# 243493
    • Styria
      • Leoben, Styria, Austria, 8700
        • Recruiting
        • Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
    • Upper Austria
      • Linz, Upper Austria, Austria, 4010
        • Recruiting
        • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
    • Vienna
      • Vienna, Vienna, Austria, 1090
        • Recruiting
        • Medizinische Universitaet Wien /ID# 230013
      • Vienna, Vienna, Austria, 1160
        • Recruiting
        • Klinik Ottakring /ID# 230019
  • Brazil
      • São Paulo, Brazil, 01236-030
        • Recruiting
        • Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Completed
        • Hospital de Clinicas de Porto Alegre /ID# 243657
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01409-001
        • Recruiting
        • Hospital Nove de Julho /ID# 243658
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • UMHAT Sveti Georgi EAD /ID# 272321
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • MHAT Hristo Botev /ID# 229687
  • Germany
      • Berlin, Germany, 10707
        • Recruiting
        • Onkologische Schwerpunktpraxis /ID# 245465
      • Berlin, Germany, 13353
        • Recruiting
        • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748
      • Bremen, Germany, 28239
        • Completed
        • Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen /ID# 230181
      • Halle, Germany, 06120
        • Recruiting
        • Universitaetsklinikum Halle (Saale) /ID# 245350
      • Hamburg, Germany, 22081
        • Recruiting
        • OncoResearch Lerchenfeld GmbH /ID# 230191
      • Landshut, Germany, 84034
        • Recruiting
        • Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
      • Paderborn, Germany, 33098
        • Recruiting
        • Bruederkrankenhaus St. Josef Paderborn /ID# 230177
    • Baden-Wurttemberg
      • Mutlangen, Baden-Wurttemberg, Germany, 73557
        • Recruiting
        • Stauferklinikum Schwaebisch Gmuend /ID# 230176
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Recruiting
        • Universitaetsklinikum Ulm /ID# 230164
    • Bavaria
      • Landshut, Bavaria, Germany, 84036
        • Recruiting
        • VK&K Studien GbR /ID# 230198
      • Munich, Bavaria, Germany, 80804
        • Completed
        • Muenchen Klinik Schwabing /ID# 230197
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
        • Recruiting
        • Universitaetsmedizin Rostock /ID# 230190
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Recruiting
        • Universitaetsklinikum Koeln /ID# 230296
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Recruiting
        • Universitaetsklinikum des Saarlandes /ID# 248747
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Recruiting
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
  • Israel
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center. /ID# 243220
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 91120
        • Recruiting
        • Hadassah /ID# 245059
    • Tel Aviv
      • Ramat Gan, Tel Aviv, Israel, 5265601
        • Recruiting
        • The Chaim Sheba Medical Center /ID# 243219
      • Tel Aviv, Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center /ID# 243218
  • Italy
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera Santa Maria Terni /ID# 229442
    • Piedmont
      • Turin, Piedmont, Italy, 10126
        • Recruiting
        • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
  • Romania
    • București
      • Bucharest, București, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute /ID# 241614
  • Spain
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de la Princesa /ID# 229665
  • United Kingdom
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 8NR
        • Recruiting
        • Blackpool Victoria Hospital /ID# 267280
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust /ID# 250732
  • United States
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • Moores Cancer Center at UC San Diego /ID# 230157
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute of Emory University /ID# 230643
    • Iowa
      • Des Moines, Iowa, United States, 50309-1423
        • Completed
        • Des Moines Oncology Research Association /ID# 232606
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute /ID# 230061
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Completed
        • Henry Ford Hospital /ID# 230268
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • St. Lukes Hospital of Duluth /ID# 250021
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Recruiting
        • Hattiesburg Clinic /ID# 233443
    • New Jersey
      • Florham Park, New Jersey, United States, 07932-1049
        • Completed
        • Summit Medical Group-Florham Park /ID# 244782
      • Hackensack, New Jersey, United States, 07601-7015
        • Recruiting
        • Regional Cancer Care Associates /ID# 244620
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • University of North Carolina /ID# 233313
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Presbyterian Medical Center /ID# 230201
      • Winston-Salem, North Carolina, United States, 27103
        • Recruiting
        • Novant Health Forsyth Medical Center /ID# 249533
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University /ID# 230439
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
        • Recruiting
        • Pennsylvania Oncology Hematolo /ID# 249637
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Completed
        • University of Wisconsin-Madiso /ID# 232612

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Drug: Venetoclax
Oral tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199
Drug: Obinutuzumab
Intravenous (IV) infusion
Other Names:
  • Gazyva
  • GA101
Experimental: Cohort 2 - venetoclax + obinutuzumab
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Drug: Venetoclax
Oral tablet
Other Names:
  • Venclexta
  • ABT-199
  • GDC-0199
Drug: Obinutuzumab
Intravenous (IV) infusion
Other Names:
  • Gazyva
  • GA101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response (OR) in Cohort 1 after end of combination treatment
Time Frame: 9 months
OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Response (TTR) in Cohort 1
Time Frame: 15 months
TTR is defined as the time from first dose until first response (PR or better).
15 months
Duration of Response (DOR) in Cohort 1
Time Frame: 15 months
DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
15 months
Time to Next Treatment (TTNT) for CLL in Cohort 1
Time Frame: 15 months
TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
15 months
Progression-free Survival (PFS) in Cohort 1
Time Frame: 15 months
PFS is defined as the time from first dose until PD or death.
15 months
Overall Survival (OS) in Cohort 1
Time Frame: 15 months
OS is defined as the time from first dose until death.
15 months
OR in Cohort 1 after end of combination treatment
Time Frame: 9 months
OR rate is defined as the percentage of participants achieving a best response of CR or CRi
9 months
OR in Cohort 1 after end of treatment
Time Frame: 15 months
OR is defined as the percentage of participants achieving a best response of PR, nPR, CRi, or CR. Disease assessments will be based on the 2018 iwCLL criteria for tumor response.
15 months
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment
Time Frame: 9 months
Percentage of participants with uMRD rate, measured in peripheral blood.
9 months
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment
Time Frame: 15 months
Percentage of participants with uMRD rate, measured in peripheral blood.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M20-356
  • 2023-504599-10-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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