Bcl-2 Inhibitor + Obinutuzumab + Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKerry Rogers, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Kerry Rogers

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase Ib/II trial studies the best dose and safety of Bcl-2 inhibitor GDC-0199 in combination with obinutuzumab and ibrutinib and to see how well they work in treating patients with chronic lymphocytic leukemia that has returned (relapsed), does not respond to treatment (refractory), or is previously untreated. Bcl-2 inhibitor GDC-0199 and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as obinutuzumab, may block cancer growth in different ways by targeting certain cells. Giving Bcl-2 inhibitor GDC-0199 together with obinutuzumab and ibrutinib may be a better treatment for chronic lymphocytic leukemia.

Eligibility Criteria

This trial is for adults with Chronic Lymphocytic Leukemia (CLL) that's untreated, returned after treatment, or hasn't responded to past treatments. They should be relatively healthy otherwise (ECOG <=1), have adequate kidney function, and not pregnant or able to become pregnant without proper birth control measures. People can't join if they've had certain recent treatments, active infections like HIV or hepatitis B/C, severe allergies to monoclonal antibodies, other cancers within the last 3 years (with some exceptions), or conditions affecting drug absorption.

Inclusion Criteria

Ability to understand and willingness to sign an informed consent document

I am fully active and can carry on all pre-disease activities without restriction.

I have CLL, show symptoms, haven't had chemotherapy, and meet certain lab criteria.

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Exclusion Criteria

My cancer has specific mutations or is resistant to some treatments.

I am HIV positive.

My heart condition limits my physical activity.

See 15 more

Treatment Details

Interventions

GDC-0199 (Bcl-2 Inhibitor)
Ibrutinib (Kinase Inhibitor)
Obinutuzumab (Monoclonal Antibodies)

Trial OverviewThe trial tests a combination of drugs: GDC-0199 (a Bcl-2 inhibitor), obinutuzumab (a monoclonal antibody), and ibrutinib against CLL. It aims to find the safest doses and see how well these drugs work together in treating CLL by blocking enzymes cancer cells need for growth and targeting specific cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (obinutuzumab, ibrutinib, Bcl-2 inhibitor GDC-0199)Experimental Treatment6 Interventions

Patients receive obinutuzumab IV on day 1 (days 1, 2, 8, and 15 for course 1 only) every 28 days for up to 8 courses. Beginning in course 2, patients receive ibrutinib PO QD on days 1-28. Beginning in course 3, patients receive Bcl-2 inhibitor GDC-0199 PO QD on days 1-28. Treatment repeats every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.