Venetoclax + Obinutuzumab for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+15 other locations

Cayuga Health Welcomes Dr. Anthony Mato ...

Overseen byMeghan Thompson, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This study will help researchers collect more information about how effective the combination of venetoclax and obinutuzumab is in treating CLL in people who have not received a previous treatment for their cancer.

Eligibility Criteria

Adults with untreated chronic lymphocytic leukemia who are generally in good health and have normal organ function. They must be able to perform daily activities with ease or only limited assistance (ECOG Performance Status of 0 or 1). Participants need to agree to use effective contraception and not donate sperm or eggs. People with a history of other cancers, significant infections, liver disease, positive tests for hepatitis B/C or HIV, recent major surgery, inability to swallow tablets, known drug allergies, or those requiring warfarin are excluded.

Inclusion Criteria

AST or ALT ≤ 2.5 x ULN

My hemoglobin level is at least 8 g/dL without needing a blood transfusion.

My blood counts are within normal ranges, not affected by my condition.

+25 more

Exclusion Criteria

I had or have hidden hepatitis B but no active virus, and I agree to monthly DNA tests.

I have had treatment for CLL, but may have taken steroids for less than a week to manage symptoms.

I had surgery for early-stage, low-grade prostate cancer and currently show no signs of the disease.

+23 more

Participant Groups

The trial is testing the effectiveness of combining two drugs: Venetoclax and Obinutuzumab in treating CLL. The study includes adults who haven't been treated before for their cancer. It aims to gather more data on how well these drugs work together when given as an initial treatment.

1Treatment groups

Experimental Treatment

Group I: Venetoclax and ObinutuzumabExperimental Treatment2 Interventions

All patients will receive a minimum of 9 cycles (cycle = 28 days) of therapy with venetoclax and obinutuzumab during the treatment period. For patients who remain MRD positive at Cycle 9 of therapy, an additional 12 cycles of venetoclax monotherapy will be given.

Obinutuzumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Gazyva for: