ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 136
Summary
- Conditions
- Follicular Lymphoma ( FL)
- Burkitt Lymphoma
- CLL
- Hairy Cell Leukemia
- Hodgkin Lymphoma
- Indolent Non Hodgkin Lymphoma
- Mantle Cell Lymphoma (MCL)
- Marginal Zone Lymphomas
- Mediastinal Large B Cell Lymphoma
- Multiple Myeloma
- Richter's Syndrome
- Small Lymphocytic Lymphoma (SLL)
- Waldenstrom Macroglobulinemia
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for po...
This is a Phase 1b/2, open-label, nonrandomized study that will be conducted in 2 stages. In the first stage, Part 1 of the study will determine the safety and preliminary efficacy of acalabrutinib and pembrolizumab in a limited group of B-cell malignancies. In the second stage, Part 2 allows for possible expansion cohorts into a wider range of B-cell malignancies, and Part 3 will evaluate the combination in subjects with myelofibrosis (MF).
Tracking Information
- NCT #
- NCT02362035
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Study Director: Acerta Clinical Trials Acerta Pharma, LLC
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