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
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
2 other identifiers
interventional
75
10 countries
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2022
Longer than P75 for phase_2
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedStudy Start
First participant enrolled
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
February 9, 2026
February 1, 2026
4.6 years
May 19, 2021
February 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response (OR) in Cohort 1 after end of combination treatment
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 Outcomes (9)
OR in Cohort 1 after end of combination treatment
9 months
OR in Cohort 1 after end of treatment
15 months
Time to Response (TTR) in Cohort 1
15 months
Duration of Response (DOR) in Cohort 1
15 months
Time to Next Treatment (TTNT) for CLL in Cohort 1
15 months
- +4 more secondary outcomes
Study Arms (2)
Cohort 1 - venetoclax + obinutuzumab
EXPERIMENTALParticipants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Cohort 2 - venetoclax + obinutuzumab
EXPERIMENTALParticipants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Interventions
Oral tablet
Intravenous (IV) infusion
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- \- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (58)
Moores Cancer Center at UC San Diego /ID# 230157
La Jolla, California, 92093, United States
Winship Cancer Institute of Emory University /ID# 230643
Atlanta, Georgia, 30322, United States
Des Moines Oncology Research Association /ID# 232606
Des Moines, Iowa, 50309-1423, United States
Dana-Farber Cancer Institute /ID# 230061
Boston, Massachusetts, 02215, United States
Henry Ford Hospital /ID# 230268
Detroit, Michigan, 48202, United States
St. Lukes Hospital of Duluth /ID# 250021
Duluth, Minnesota, 55805, United States
Hattiesburg Clinic /ID# 233443
Hattiesburg, Mississippi, 39401, United States
Summit Medical Group-Florham Park /ID# 244782
Florham Park, New Jersey, 07932-1049, United States
Regional Cancer Care Associates /ID# 244620
Hackensack, New Jersey, 07601-7015, United States
University of North Carolina /ID# 233313
Chapel Hill, North Carolina, 27514, United States
Novant Health Presbyterian Medical Center /ID# 230201
Charlotte, North Carolina, 28204, United States
Novant Health Forsyth Medical Center /ID# 249533
Winston-Salem, North Carolina, 27103, United States
The Ohio State University /ID# 230439
Columbus, Ohio, 43210, United States
Pennsylvania Oncology Hematolo /ID# 249637
Philadelphia, Pennsylvania, 19106, United States
University of Wisconsin-Madiso /ID# 232612
Madison, Wisconsin, 53705, United States
Royal Adelaide Hospital /ID# 229898
Adelaide, South Australia, 5000, Australia
Northern Hospital Epping /ID# 229847
Epping, Victoria, 3076, Australia
Peter MacCallum Cancer Ctr /ID# 254634
Melbourne, Victoria, 3000, Australia
Universitaetsklinikum St. Poelten /ID# 243493
Sankt Pölten, Lower Austria, 3100, Austria
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
Leoben, Styria, 8700, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
Linz, Upper Austria, 4010, Austria
Medizinische Universitaet Wien /ID# 230013
Vienna, Vienna, 1090, Austria
Klinik Ottakring /ID# 230019
Vienna, Vienna, 1160, Austria
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
Salzburg, 5020, Austria
Hanusch Krankenhaus /ID# 230010
Vienna, 1140, Austria
Hospital de Clinicas de Porto Alegre /ID# 243657
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Nove de Julho /ID# 243658
São Paulo, São Paulo, 01409-001, Brazil
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
São Paulo, 01236-030, Brazil
UMHAT Sveti Georgi EAD /ID# 272321
Plovdiv, 4002, Bulgaria
MHAT Hristo Botev /ID# 229687
Vratsa, 3000, Bulgaria
Stauferklinikum Schwaebisch Gmuend /ID# 230176
Mutlangen, Baden-Wurttemberg, 73557, Germany
Universitaetsklinikum Ulm /ID# 230164
Ulm, Baden-Wurttemberg, 89081, Germany
VK&K Studien GbR /ID# 230198
Landshut, Bavaria, 84036, Germany
Muenchen Klinik Schwabing /ID# 230197
Munich, Bavaria, 80804, Germany
Universitaetsmedizin Rostock /ID# 230190
Rostock, Mecklenburg-Vorpommern, 18057, Germany
Universitaetsklinikum Koeln /ID# 230296
Cologne, North Rhine-Westphalia, 50937, Germany
Universitaetsklinikum des Saarlandes /ID# 248747
Homburg, Saarland, 66424, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168
Dresden, Saxony, 01307, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
Kiel, Schleswig-Holstein, 24105, Germany
Onkologische Schwerpunktpraxis /ID# 245465
Berlin, 10707, Germany
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748
Berlin, 13353, Germany
Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
Bremen, 28239, Germany
Universitaetsklinikum Essen /ID# 230181
Essen, 45147, Germany
Universitaetsklinikum Halle (Saale) /ID# 245350
Halle, 06120, Germany
OncoResearch Lerchenfeld GmbH /ID# 230191
Hamburg, 22081, Germany
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
Landshut, 84034, Germany
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
Paderborn, 33098, Germany
Hadassah /ID# 245059
Jerusalem, Jerusalem, 91120, Israel
The Chaim Sheba Medical Center /ID# 243219
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 243218
Tel Aviv, Tel Aviv, 6423906, Israel
Rabin Medical Center. /ID# 243220
Petah Tikva, 4941492, Israel
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
Turin, Piedmont, 10126, Italy
Azienda Ospedaliera Santa Maria Terni /ID# 229442
Terni, 05100, Italy
Fundeni Clinical Institute /ID# 241614
Bucharest, București, 022328, Romania
Hospital Universitario de la Princesa /ID# 229665
Madrid, 28006, Spain
Blackpool Victoria Hospital /ID# 267280
Blackpool, Lancashire, FY3 8NR, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
Norwich, Norfolk, NR4 7UY, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 250732
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 20, 2021
Study Start
March 28, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
January 1, 2029
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.