Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib and pembrolizumab in hematologic malignancies.

Official Title

A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 (Acalabrutinib) and Pembrolizumab in Subjects With Hematologic Malignancies

Details

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).

Keywords

Follicular Lymphoma (FL), CLL, Small Lymphocytic Lymphoma (SLL), Richter's Syndrome, Mantle Cell Lymphoma (MCL), Indolent Non Hodgkin Lymphoma, Waldenström Macroglobulinemia, Multiple Myeloma, Hodgkin Lymphoma, Burkitt Lymphoma, Marginal Zone Lymphomas, Mediastinal Large B Cell Lymphoma, Hairy Cell Leukemia, Bruton tyrosine kinase inhibitor, Btk, B-Cell Malignancies, Mantle Cell, SLL, DLBCL, Follicular, Waldenstrom, B cell acute lymphoid leukemia, Acalabrutinib, ACP-196, Lymphoma, Leukemia, Neoplasms, Mantle-Cell Lymphoma, Lymphoma, B-Cell, Marginal Zone, Leukemia, Lymphocytic, Chronic, B-Cell, Hematologic Neoplasms, Waldenstrom Macroglobulinemia, Pembrolizumab, Acalabrutinib plus Pembrolizumab

Eligibility

Locations

  • Research Site
    Los Angeles California 90095 United States
  • Research Site
    Tucson Arizona 85704 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acerta Pharma BV
Links
Redacted CSP Redacted SAP
ID
NCT02362035
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 161 people participating
Last Updated