Acalabrutinib in Combination With Anti-CD20 and Venetoclax in Relapsed/Refractory or Untreated CLL/SLL/PLL
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 45
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Prolymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 125 years
- Gender
- Both males and females
Description
A Phase 1b Study of ACP-196 in Combination with Obinutuzumab for Patients with Relapsed/Refractory or Untreated CLL/SLL/PLL Study started with two cohorts, on Acalabrutinib and Obinutuzumab, cohort 1 for relapsed or refractory patients and cohort two for treatment naïve subjects. Then for longer sur...
A Phase 1b Study of ACP-196 in Combination with Obinutuzumab for Patients with Relapsed/Refractory or Untreated CLL/SLL/PLL Study started with two cohorts, on Acalabrutinib and Obinutuzumab, cohort 1 for relapsed or refractory patients and cohort two for treatment naïve subjects. Then for longer survival data and combination therapy, two new cohorts added to the study, cohort 3 with relapsed or refractory subjects on Acalabrutinib, Rituximab and Venetoclax, and cohort 4 with treatment naïve subjects on Acalabrutinib, Obinutuzumab and Venetoclax. Primary endpoints: For Cohorts 1 and 2, the ORR (PR or better) at the 12-month response assessment will be calculated and 95% exact binomial CIs will be provided. For Cohorts 1 to 4, toxicities will be tabulated by type and grade using NCI-CTCAE version 4.03 criteria or higher and displayed in summary form. Currently study is in maintenance phase and we don't expect a major change in the near future.
Tracking Information
- NCT #
- NCT02296918
- Collaborators
- Not Provided
- Investigators
- Study Director: AstraZeneca Study Information Center 1-877-240-9479; information.center@astrazeneca.com