Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/17/2019 |
| Start Date: | October 2016 |
| End Date: | December 2020 |
Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
This is a multicenter, 2-cohort Phase 2 study assessing both MRD-guided discontinuation and
fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with
treatment-naïve CLL or SLL
fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with
treatment-naïve CLL or SLL
Inclusion Criteria:
- Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008), with active
disease meeting at least 1 IWCLL criteria for requiring treatment.
- Measurable nodal disease by computed tomography (CT)
- Adequate hepatic, and renal function
- Adequate hematologic function
- absolute neutrophil count >750/µL
- platelet count >30,000 /μL
- hemoglobin >8.0 g/dL
Exclusion Criteria:
- Any prior therapy used for treatment of CLL/SLL
- Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk
for TLS
We found this trial at
15
sites
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