Phase 2 Study of Duvelisib in Previously Treated Patients With Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma
NCT03370185 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2023-02-28
Summary
This is a multi-center, single-arm, open-label, Phase 2 study of duvelisib, an orally bioavailable dual inhibitor of PI3K-δ,γ, in patients with CLL/SLL who have previously been treated with ibrutinib or another Bruton's Tyrosine Kinase Inhibitor (BTKi) and relapsed or were refractory to such therapy or discontinued such therapy due to toxicity.
Conditions
Interventions
- DRUG
-
Duvelisib
Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
Sponsors & Collaborators
-
SecuraBio
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-12
- Primary Completion
- 2020-06-30
- Completion
- 2021-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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