A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)
NCT02004522 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 319
Last updated 2023-09-21
Summary
A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).
Conditions
Interventions
- DRUG
-
Duvelisib
PI3K Inhibitor
- DRUG
-
Ofatumumab
monoclonal antibody
Sponsors & Collaborators
-
SecuraBio
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-11-30
- Primary Completion
- 2017-05-19
- Completion
- 2021-06-30
Countries
- United States
- Australia
- Austria
- Belgium
- France
- Germany
- Hungary
- Italy
- New Zealand
- Spain
- United Kingdom
Study Locations
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