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

Launched by ACERTA PHARMA BV · Feb 7, 2015

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of two medications, acalabrutinib and pembrolizumab, when used together to treat certain types of blood cancers, including follicular lymphoma, chronic lymphocytic leukemia, and multiple myeloma, among others. The goal is to see how well this combination works and how it affects patients' bodies.

To participate in this trial, individuals must have a documented diagnosis of one of the specified blood cancers and have a good performance status, meaning they should be able to carry out daily activities with minimal assistance. They also need to have completed any prior cancer treatments at least four weeks before starting the study. Participants can expect regular check-ups and monitoring during the trial to ensure their safety and to track how well the treatment is working. It's important to note that this trial is currently active but not enrolling new participants, and it is designed for both men and women aged 65 to 74.

Gender

ALL

Eligibility criteria

• Main 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.
• Main 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.