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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02157324
Recruitment Status : Active, not recruiting
First Posted : June 6, 2014
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: acalabrutinib Drug: ACP-319 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2014
Estimated Primary Completion Date : July 2020

Arm Intervention/treatment
Experimental: acalabrutinib
Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.
Drug: acalabrutinib
Other Name: ACP-196

Drug: ACP-319
Experimental: ACP-319
Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.
Drug: acalabrutinib
Other Name: ACP-196

Drug: ACP-319

Primary Outcome Measures :
  1. Characterize the pharmacokinetics of acalabrutinib and ACP-319 [ Time Frame: Cycle 1 (28 Days) ]
    Assess the change in exposure (Cmax and AUC) in acalabrutinib and ACP-319 when given in combination versus when each drug is given alone

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women ≥ 18 years of age with a confirmed diagnosis of CLL, which has relapsed after, or been refractory to, ≥ 1 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 acalabrutinib 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02157324

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United States, Ohio
Columbus, Ohio, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Acerta Pharma BV
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Study Director: Acerta Clinical Trials 1-888-292-9613
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Responsible Party: Acerta Pharma BV Identifier: NCT02157324    
Other Study ID Numbers: ACE-CL-002
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action