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

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

sites

Clinical Trial Facility in Kogarah New South Wales

Kogarah, New South Wales 2217

from

Kogarah,