Clinical Trials /

An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

NCT02213926

Description:

The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Related Conditions:
  • Anaplastic Large Cell Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02213926

Trial Eligibility

Document

An Open-label, Phase 2 Study of ACP 196 in Subjects With Mantle Cell <span class="go-doc-concept go-doc-disease">Lymphoma</span>

Title

  • Brief Title: An Open-label, Phase 2 Study of ACP 196 in Subjects With Mantle Cell Lymphoma
  • Official Title: An Open-label, Phase 2 Study of ACP 196 in Subjects With Mantle Cell Lymphoma

    • Clinical Trial IDs

    NCT ID: NCT02213926

    ORG ID: ACE-LY-004

    Trial Conditions

    Mantle Cell Lymphoma (MCL)

    Trial Interventions

    Drug Synonyms Arms
    ACP-196 ACP-196 Regimen 1

    Trial Purpose

    The purpose of this study is to characterize the safety and efficacy profile of ACP-196 in
    subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    ACP-196 Regimen 1 Experimental ACP-196 Regimen 1 ACP-196

    Eligibility Criteria

    Inclusion criteria:

    - Men and women 18 years of age.

    - Pathologically confirmed MCL, with documentation of monoclonal B cells that have a
    chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.

    - Eastern Cooperative Oncology Group (ECOG) performance status of 2.

    - Agreement to use contraception during the study and for 30 days after the last dose
    of study drugs if sexually active and able to bear or beget children.

    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 ACP-196, or put the study outcomes at undue risk

    - Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
    congestive heart failure, or myocardial infarction within 6 months of screening, or
    any Class 3 or 4 cardiac disease as defined by the New York Heart Association
    Functional Classification, or corrected QT interval (QTc) > 480 msec.

    - Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
    resection of the stomach or small bowel or ulcerative colitis, symptomatic
    inflammatory bowel disease, or partial or complete bowel obstruction.

    - Breast feeding or pregnant

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Overall response rate (ORR) of ACP-196 in subjects with previously treated MCL.

    Secondary Outcome Measures

    Trial Keywords

    Bruton tyrosine kinase inhibitor

    Btk

    Mantle Cell Lymphoma

    MCL

    ACP-196