Clinical Trials /

Acalabrutinib in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia

NCT02157324

Description:

This study is evaluating the safety and efficacy of the combined use of acalabrutinib and ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

ACP-196 in Combination With ACP-319, for Treatment of <span class="go-doc-concept go-doc-disease">Chronic Lymphocytic Leukemia</span>

Title

  • Brief Title: ACP-196 in Combination With ACP-319, for Treatment of Chronic Lymphocytic Leukemia
  • Official Title: A Multicenter, Open-label, Phase 1 Pilot Study of ACP 196 in Combination With ACP-319 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
  • Clinical Trial IDs

    NCT ID: NCT02157324

    ORG ID: ACE-CL-002

    Trial Conditions

    Chronic Lymphocytic Leukemia

    Trial Interventions

    Drug Synonyms Arms
    ACP-196 and ACP-319 ACP-196 then in combination with ACP-319

    Trial Purpose

    This study is evaluating the safety and efficacy of the combined use of ACP-196 and ACP-319,
    for the treatment of chronic lymphocytic leukemia (CLL)

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    ACP-196 then in combination with ACP-319 Experimental ACP-196 and ACP-319

    Eligibility Criteria

    Inclusion Criteria:

    - Men and women 18 years of age with a confirmed diagnosis of CLL, which has relapsed
    after, or been refractory to, 2 previous treatments for CLL; however, subjects with
    17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior
    treatment for CLL.

    - 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:

    - Prior malignancy, except for adequately treated basal cell or squamous cell skin
    cancer, in situ cervical cancer, or other cancer from which the subject has been
    disease free for 2 years or which will not limit survival to < 2 years.

    - 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 and/or ACP-319, or put the study outcomes at
    undue risk.

    - Significant cardiovascular disease.

    - 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.

    - Any immunotherapy within 4 weeks of first dose of study drug.

    - For subjects with recent chemotherapy or experimental therapy the first dose of study
    drug must occur after 5 times the half-life of the agent(s).

    - History of prior allogeneic bone marrow progenitor cell or solid organ
    transplantation.

    - Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for
    treatment of CLL or other conditions. Note: Subjects may be using topical or inhaled
    corticosteroids as therapy for comorbid conditions.

    - Central nervous system (CNS) involvement by CLL.

    - Grade 2 toxicity (other than alopecia).

    - Known history of human immunodeficiency virus (HIV) or active infection with
    hepatitis C virus (HCV) or hepatitis B virus (HBV) or any uncontrolled active
    systemic infection.

    - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.

    - Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count < 50 x 109/L unless
    due to disease involvement in the bone marrow.

    - Creatinine > 1.5 x institutional upper limit of normal (ULN); total bilirubin > 1.5 x
    ULN (unless due to Gilbert's disease); and aspartate aminotransferase (AST) or
    alanine aminotransferase (ALT) > 2.5 x ULN unless disease related.

    - Significant screening ECG abnormalities including left bundle branch block, 2nd
    degree AV block type II, 3rd degree block, Grade 2 or higher bradycardia, and QTc >
    480 msec.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Characterize the pharmacokinetics of ACP-196 and ACP-319

    Secondary Outcome Measures

    Trial Keywords

    Bruton tyrosine kinase inhibitor

    Btk