Obinutuzumab + Venetoclax vs. Chlorambucil for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+205 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Hoffmann-La Roche

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults with untreated chronic lymphocytic leukemia (CLL) who have a life expectancy over 6 months and require treatment. They should not have severe other illnesses, must be able to use effective contraception, and cannot have central nervous system involvement or uncontrolled autoimmune conditions.

Inclusion Criteria

I have chronic lymphocytic leukemia that has not been treated before.

Life expectancy > 6 months

My blood cell counts are good without needing extra help, unless it's because of my CLL.

+4 more

Exclusion Criteria

Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen [HBsAg] serology) or positive test result for hepatitis C (hepatitis C virus [HCV] antibody serology testing)

I am not infected with HIV or HTLV-1.

I haven't had a serious infection needing treatment in the last 2 months.

+13 more

Participant Groups

The study compares two treatments for CLL: Obinutuzumab combined with Venetoclax versus Obinutuzumab with Chlorambucil. It's an open-label, multicenter trial where participants are randomly assigned to either regimen for about one year, followed by up to nine years of follow-up.

3Treatment groups

Experimental Treatment

Group I: Safety Run-in Obinutuzumab + VenetoclaxExperimental Treatment2 Interventions

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

Group II: Obinutuzumab + VenetoclaxExperimental Treatment2 Interventions

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

Group III: Obinutuzumab + ChlorambucilExperimental Treatment2 Interventions

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