Status:
ACTIVE_NOT_RECRUITING
Venetoclax With High-dose Ibrutinib for CLL Progressing on Single Agent Ibrutinib
Lead Sponsor:
Michael Choi
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to investigate whether the combination of venetoclax and ibrutinib (administered up to 840 mg per day) might be useful for the treatment of CLL or SLL that is not respondin...
Detailed Description
This is phase 1 study for patients with CLL or small lymphocytic lymphoma (SLL) experiencing disease progression on single ibrutinib. This study will evaluate the optimal ibrutinib dose (including dos...
Eligibility Criteria
Inclusion
- Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.
- Prior therapy: Patients must have been receiving single agent ibrutinib therapy at the time of disease progression. Patient may have received other therapy in combination with ibrutinib earlier in their treatment course.
- Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study.
- Adequate hematologic, hepatic and renal function
Exclusion
- Known CNS lymphoma or leukemia
- History of Richter's or prolymphocytic transformation.
- Primary ibrutinib resistance
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura (ITP)
- History of major surgery within 4 weeks prior to first dose on this study.
- History of prior malignancy, with the exception of adequately treated non-melanoma skin cancer, malignancies treated with curative intent and with no evidence of active disease for more than 3 years, or adequately treated cervical carcinoma in situ without current evidence of disease.
- Active clinically significant cardiovascular disease or history of myocardial infarction within 6 months of first dose.
- Active hepatitis B or C infection.
- Known history of infection with human immunodeficiency virus (HIV).
- Unable to swallow capsules or disease significantly affecting gastrointestinal function.
- History of stroke or intracranial hemorrhage within 6 months of first dose.
- Requires anticoagulation with warfarin or other Vitamin K antagonists.
- Requires treatment with a strong cytochrome P(CYP)450 3A inhibitor.
- Pregnant or breast-feeding women
- Current infection requiring parenteral antibiotics.
- Active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.
- Patients who require immediate cytoreduction due to high risk of tumor lysis syndrome (ie, absolute lymphocyte count greater than 100k/uL).
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03422393
Start Date
May 1 2018
End Date
August 1 2028
Last Update
July 5 2024
Active Locations (1)
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1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093