Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

ACP-196 (Acalabrutinib) in Combination With Pembrolizumab, for Treatment of Hematologic Malignancies

Protocol: OSU-14272

Full Title

A Phase 1b/2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with B-cell Malignancies

Purpose

This study is evaluating the safety, pharmacodynamics (PD), and efficacy of acalabrutinib

and pembrolizumab in hematologic malignancies.

Are you eligible?

Inclusion Criteria:

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 10^9/L or platelet count ≥ 50 x 10^9/L unless due to disease involvement

in the bone marrow.

Exclusion Criteria:

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.

Non-Hodgkin’s Lymphoma (B- & T-Cell) Multiple Myeloma Lymphoma Hodgkin’s Lymphoma