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

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego
• Collaborator: Pharmacyclics LLC.
• Treatments: Obinutuzumab

Criteria

Inclusion Criteria:

1. Diagnosis of CLL

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

3. No previous treatment for CLL

4. Males and females 65 years of age and older. Subjects under 65 years of age that meet any of the following criteria:

A. Documented refusal to be treated with chemotherapy agents B. Subjects that are not candidates for treatment with chemotherapy based on poor performance status (ECOG g>= 2), Cumulative Illness Rating Scale (CIRS score) >= 6 or creatinine clearance less than 70 mL/min

5. Adequate hematologic, hepatic, and renal function

6. Anticipated survival of at least 6 months

7. Effective contraception is required while receiving Ibrutinib in combination with GA101-Obinutuzumab. For women of childbearing potential and men, effective contraception is required while receiving GA101-Obinutuzumab and for 365 days (12 months) after the last dose of the study drug

Exclusion Criteria:

1. Pregnant or nursing women

2. Treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial

3. Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification

4. Severe or debilitating pulmonary disease

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

6. 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.

7. Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status.

8. Evidence of active acute or chronic Hepatitis B (HBV)

9. Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology and positive HCV RNA test

10. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy

11. Known hypersensitivity to any of the study drugs

12. Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes

13. Vaccination with a live vaccine within 28 days of the initiation of treatment.

14. Concomitant use of warfarin or other Vitamin K antagonists

15. Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor

16. Chronic liver disease with hepatic impairement (Child-Pugh class B or C)