Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL
NCT02296918 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69
Last updated 2025-12-19
Summary
To evaluate the safety and preliminary efficacy of acalabrutinib in combination with obinutuzumab in 4 separate cohorts of participants.
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Prolymphocytic Leukemia
Interventions
- DRUG
-
Participants will receive oral acalabrutinib in Cohorts 1, 2, 3, and 4. The details are mentioned in the cohort description.
- DRUG
-
Participants will receive intravenous obinutuzumab in Cohorts 1, 2, and 4. The details are mentioned in the cohort description.
- DRUG
-
Participants will receive oral venetoclax in Cohorts 3 and 4. The details are mentioned in the cohort description.
- DRUG
-
Participants will receive intravenous rituximab in Cohort 3. The details are mentioned in the cohort description.
Sponsors & Collaborators
-
Acerta Pharma BV
lead INDUSTRY
Principal Investigators
-
AstraZeneca Study Information Center · 1-877-240-9479; [email protected]
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-12-22
- Primary Completion
- 2021-08-20
- Completion
- 2025-10-22
Countries
- United States
Study Locations
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