Ibrutinib in Combination With GA101 (Obinutuzumab) in Previously Untreated Chronic Lymphocytic Leukemia (CLL) Patients.
Completed · Phase 1/Phase 2
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT02315768
- Run by
- University of California, San Diego
- People needed
- 32
- Starts
- 2015-08-26
- Expected to finish
- 2022-04-18
- Last updated by the study team
- 2025-09-15
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of CLL
- Indication for treatment as defined by the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) Guidelines
- No previous treatment for CLL
- 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
- Adequate hematologic, hepatic, and renal function
- Anticipated survival of at least 6 months
- 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
You may not qualify if…
- Pregnant or nursing women
- Treatment with chemotherapy, monoclonal antibodies, or biological agents (e.g. lenalidomide) other than the investigational agents during the time of participation in this trial
- Grade 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Severe or debilitating pulmonary disease
- 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.
- Active symptomatic fungal, bacterial and/or viral infection including evidence of infection with HIV, human T-cell leukemia virus 1 (HTLV-1) seropositive status.
- Evidence of active acute or chronic Hepatitis B (HBV)
- Evidence of active Hepatitis C (HCV): subjects with positive hepatitis C serology and positive HCV RNA test
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
- Known hypersensitivity to any of the study drugs
- Major surgery (within 4 weeks prior to the start of Cycle 1), except for procedures that are performed for diagnostic purposes
- Vaccination with a live vaccine within 28 days of the initiation of treatment.
- Concomitant use of warfarin or other Vitamin K antagonists
- Requirement to receive treatment with a strong cytochrome P450 (CYP) 3A inhibitor
- Chronic liver disease with hepatic impairment (Child-Pugh class B or C)
Where it is running
- UCSD Moores Cancer Center — La Jolla, California, United States
Full record on ClinicalTrials.gov
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