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)

NCT04895436 · tracked via the Priya Life Science UK tracker

Sponsor

AbbVie

Phase

Phase 2

Started

2022-03-28

Last updated

2026-02-09

Condition(s) studied

Chronic Lymphocytic Leukemia (CLL)

Investigational drug(s) / intervention(s)

VenetoclaxObinutuzumab

Venetoclax: Oral tablet

Obinutuzumab: Intravenous (IV) infusion

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Overall response (OR) in Cohort 1 after end of combination treatment — 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.

Trial sites (58)

Facility	City	Region	Status
Moores Cancer Center at UC San Diego /ID# 230157	La Jolla	California	Recruiting
Winship Cancer Institute of Emory University /ID# 230643	Atlanta	Georgia	Recruiting
Des Moines Oncology Research Association /ID# 232606	Des Moines	Iowa	Completed
Dana-Farber Cancer Institute /ID# 230061	Boston	Massachusetts	Recruiting
Henry Ford Hospital /ID# 230268	Detroit	Michigan	Completed
St. Lukes Hospital of Duluth /ID# 250021	Duluth	Minnesota	Recruiting
Hattiesburg Clinic /ID# 233443	Hattiesburg	Mississippi	Recruiting
Summit Medical Group-Florham Park /ID# 244782	Florham Park	New Jersey	Completed
Regional Cancer Care Associates /ID# 244620	Hackensack	New Jersey	Recruiting
University of North Carolina /ID# 233313	Chapel Hill	North Carolina	Recruiting
Novant Health Presbyterian Medical Center /ID# 230201	Charlotte	North Carolina	Recruiting
Novant Health Forsyth Medical Center /ID# 249533	Winston-Salem	North Carolina	Recruiting
The Ohio State University /ID# 230439	Columbus	Ohio	Recruiting
Pennsylvania Oncology Hematolo /ID# 249637	Philadelphia	Pennsylvania	Recruiting
University of Wisconsin-Madiso /ID# 232612	Madison	Wisconsin	Completed
Royal Adelaide Hospital /ID# 229898	Adelaide	South Australia	Recruiting
Northern Hospital Epping /ID# 229847	Epping	Victoria	Recruiting
Peter MacCallum Cancer Ctr /ID# 254634	Melbourne	Victoria	Recruiting
Universitaetsklinikum St. Poelten /ID# 243493	Sankt Pölten	Lower Austria	Recruiting
Medizinische Universitaet Wien /ID# 230013	Vienna	State of Vienna	Recruiting
Klinik Ottakring /ID# 230019	Vienna	State of Vienna	Recruiting
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569	Leoben	Styria	Recruiting
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516	Linz	Upper Austria	Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015	Salzburg	Austria	Completed
Hanusch Krankenhaus /ID# 230010	Vienna	Austria	Recruiting
Hospital de Clinicas de Porto Alegre /ID# 243657	Porto Alegre	Rio Grande do Sul	Completed
Hospital Nove de Julho /ID# 243658	São Paulo	São Paulo	Recruiting
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659	São Paulo	Brazil	Recruiting
UMHAT Sveti Georgi EAD /ID# 272321	Plovdiv	Bulgaria	Recruiting
MHAT Hristo Botev /ID# 229687	Vratsa	Bulgaria	Recruiting
Stauferklinikum Schwaebisch Gmuend /ID# 230176	Mutlangen	Baden-Wurttemberg	Recruiting
Universitaetsklinikum Ulm /ID# 230164	Ulm	Baden-Wurttemberg	Recruiting
VK&K Studien GbR /ID# 230198	Landshut	Bavaria	Recruiting
Muenchen Klinik Schwabing /ID# 230197	Munich	Bavaria	Completed
Universitaetsmedizin Rostock /ID# 230190	Rostock	Mecklenburg-Vorpommern	Recruiting
Universitaetsklinikum Koeln /ID# 230296	Cologne	North Rhine-Westphalia	Recruiting
Universitaetsklinikum des Saarlandes /ID# 248747	Homburg	Saarland	Recruiting
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168	Dresden	Saxony	Recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186	Kiel	Schleswig-Holstein	Recruiting
Onkologische Schwerpunktpraxis /ID# 245465	Berlin	Germany	Recruiting

+ 18 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04895436 on ClinicalTrials.gov ↗ ← All trials in the UK