Summary

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

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 Lymphoma, Mantle-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, Lymphocytic, Chronic, B-Cell Hematologic Neoplasms Waldenstrom Macroglobulinemia Leukemia, Hairy Cell Pembrolizumab ACP-196 (Acalabrutinib) +PEM

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of a hematologic malignancy as documented by medical records and with histology based on criteria established by the World Health Organization (WHO).
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Agreement to use contraception during the study and for 90 days after the last dose of ACP-196 or 120 days after the last dose of pembrolizumab, if sexually active and able to bear or beget children.
  • Completion of all therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥ 4 weeks before the start of study therapy.
  • ANC ≥ 0.5 x 109/L or platelet count ≥ 50 x 109/L unless due to disease involvement in the bone marrow.

You CAN'T join if...

  • A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of study drugs, or put the study outcomes at undue risk.
  • Central nervous system (CNS) involvement by lymphoma/leukemia
  • Any therapeutic antibody within 4 weeks of first dose of study drugs.
  • Total bilirubin > 1.5 x ULN; and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3.0 x ULN.
  • Estimated creatinine clearance of < 30 mL/min, calculated using the formula of Cockcroft and Gault (140-Age) • Mass (kg)/(72 • creatinine mg/dL); multiply by 0.85 if female.

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
ID
NCT02362035
Phase
Phase 1/2
Study Type
Interventional
Last Updated