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

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Kerry Rogers

Must not be taking: Warfarin, CYP3A4 inhibitors, others

Disqualifiers: Autoimmune anemia, CNS involvement, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 14 months

87 Participants Needed

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.

Research Team

Kerry Rogers, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

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.

Exclusion Criteria

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

I am HIV positive.

My heart condition limits my physical activity.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive obinutuzumab, ibrutinib, and Bcl-2 inhibitor GDC-0199 in a phased manner over 14 courses

14 months

Monthly visits for each course

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

Follow-up at 4 and 8 weeks, every 3 months for 2 years, then every 6 months

Treatment Details

Interventions

• GDC-0199
• Ibrutinib
• Obinutuzumab

Trial Overview The 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

Group I: Treatment (obinutuzumab, ibrutinib, Bcl-2 inhibitor GDC-0199) Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

Kerry Rogers

Lead Sponsor

Trials

3

Recruited

120+