Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.

Recruiting in Palo Alto (17 mi)

Overseen byThomas E Kipps, MD, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of the study is to determine whether ibrutinib in combination with GA101 - Obinutuzumab might be useful for the treatment of CLL. This study will evaluate if ibrutinib in combination with GA101 - Obinutuzumab can reduce the amount of cancerous cells in body.

Eligibility Criteria

Inclusion Criteria

Diagnosis of CLL

Indication for treatment as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) Guidelines

No previous treatment for CLL

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Exclusion Criteria

Pregnant or nursing women

Participation in any investigational drug study within 28 days prior to initiation of treatment within this protocol

History of second malignancy, other than non-melanoma skin cancer or in situ carcinoma of the cervix or the breast, unless the tumor was successfully treated at least 2 years before trial entry and with no evidence of relapse or active cancer

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Participant Groups

1Treatment groups

Experimental Treatment

Group I: GA101+ibrutinibExperimental Treatment2 Interventions

Ibrutinib 420 mg (140 mg capsules 3 times) orally once daily for up to 6 cycles. GA101 (Obinutuzumab) by Intravenous infusion for up to 6 cycles (28 day cycles) as follows: * Cycle 1, Day 1,100 mg GA101 obinutuzumab will be administered. * Cycle 1, Day 2, 900 mg of GA101 obinutuzumab will be administered. * Cycle 1, Days 8 and 15,1,000 mg of GA101 obinutuzumab will be administered. * Cycles 2-6, Day 1, 1,000 mg of GA101 obinutuzumab will be administered.