Completed

Obinutuzumab and Venetoclax for Untreated CLL with Coexisting Conditions

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Study Aim

The study aims to evaluate the effectiveness of Obinutuzumab and Venetoclax in improving the progression-free survival of individuals with untreated chronic lymphocytic leukemia who have other health conditions.

What is being tested

Chlorambucil

+ Obinutuzumab

+ Venetoclax

Drug
Who is being recruted

Chronic Disease+13

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 18 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2014
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 31, 2014

Actual date on which the first participant was enrolled.

This clinical trial is investigating the effectiveness and safety of two different treatment combinations for people with chronic lymphocytic leukemia (CLL) who also have other health issues. The study compares the outcomes of using obinutuzumab and venetoclax versus obinutuzumab and chlorambucil. These medications aim to improve how well patients manage their CLL without worsening their other medical conditions. By finding a more effective treatment, this study hopes to provide better options for those who have not yet been treated for CLL, potentially improving their quality of life and managing the disease more effectively. Participants in this study will receive one of the two treatment combinations: either obinutuzumab with venetoclax or obinutuzumab with chlorambucil. The treatment period lasts about a year, with follow-ups extending up to nine years to monitor long-term effects and outcomes. The main focus is on measuring 'progression-free survival,' which tracks the time before the disease gets worse or any cause of death occurs. This includes monitoring changes like increased lymphocyte counts or the appearance of new lymph nodes. Participants will be closely observed to determine which treatment works best in stopping the disease progression while considering safety and tolerability.

Official TitleA 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
Principal SponsorHoffmann-La Roche
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

445 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseHematologic DiseasesHemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLeukemiaLeukemia, LymphoidLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellDisease Attributes

Criteria

7 inclusion criteria required to participate
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
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16 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive obinutuzumab for 6 cycles and chlorambucil for 12 cycles. Cycles will comprise 28 days.

Group II

Experimental
Participants will receive obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles will comprise 28 days.

Group III

Experimental
Subjects received obinutuzumab for 6 cycles and venetoclax for 12 cycles. Cycles comprised of 28 days.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 122 locations

Suspended

Banner MD Anderson Cancer Center

Gilbert, United StatesOpen Banner MD Anderson Cancer Center in Google Maps
Suspended

City of Hope

Duarte, United States
Suspended

UC San Diego Health System

La Jolla, United States
Suspended

Moffitt Cancer Center

Tampa, United States
Completed122 Study Centers