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Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

A Prospective, Open-Label, Multicenter Randomized Phase III Trial to Compare The Efficacy and Safety of A Combined Regimen of Obinutuzumab and Venetoclax Versus Obinutuzumab and Chlorambucil in Previously Untreated Patients With CLL and Coexisting Medical Conditions

NCT02242942•Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This open-label, multicenter, randomized Phase III study is designed to compare the efficacy and safety of a combined regimen of obinutuzumab and venetoclax versus obinutuzumab + chlorambucil in participants with chronic lymphocytic leukemia (CLL) and coexisting medical conditions. The time on study treatment was approximately one year and the follow-up period will be up to 9 years

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria
•CLL requiring treatment according to IWCLL criteria
•Total Cumulative Illness Rating Scale (CIRS score) greater than (\>) 6
•Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
•Adequate liver function
•Life expectancy \> 6 months
•Agreement to use highly effective contraceptive methods per protocol

Exclusion Criteria

•Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia)
•Known central nervous system involvement
•Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
•An individual organ/ system impairment score of 4 as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
•Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
•Inadequate renal function
•History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy
•Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration
•Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration
•History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
+6 more criteria

Locations (122)

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

City of Hope

Duarte, California, United States

UC San Diego Health System

La Jolla, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute

Atlanta, Georgia, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Henry Ford Hospital

Detroit, Michigan, United States

Joe Arrington Cancer Center

Lubbock, Texas, United States

Hospital Italiano

Buenos Aires, Argentina

Liverpool Hospital

Liverpool BC, New South Wales, Australia

Key Dates

Start Date

December 31, 2014

Primary Completion Date

August 17, 2018

Completion Date

August 27, 2025

Last Updated

November 6, 2025

Enrollment

445

ACTUAL participants

Conditions

Lymphocytic Leukemia, Chronic

Interventions

Chlorambucil

DRUG

Venetoclax

DRUG

Obinutuzumab

DRUG

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

NCT01283386

Lymphocytic Leukemia, Chronic

View study

COMPLETEDPHASE1

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

NCT01292603

Lymphocytic Leukemia, Chronic

View study

COMPLETED

Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 6, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Comparison of the Treatments of Obinutuzumab + Venetoclax Versus Obinutuzumab + Chlorambucil in Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria

Exclusion Criteria

A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

An Observational Study on The Health Related Quality of Life in Patients With Chronic Lymphocytic Leukaemia