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ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (Btk) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT02029443
Recruitment Status : Unknown
Verified December 2016 by Acerta Pharma BV.
Recruitment status was:  Active, not recruiting
First Posted : January 8, 2014
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Study Description
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Brief Summary:
This study is evaluating the safety and efficacy of a new Bruton tyrosine kinase (Btk) inhibitor, acalabrutinib, for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Richter's Syndrome Prolymphocytic Leukemia Drug: acalabrutinib Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 286 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Multicenter, Open-label, and Dose-escalation Study of ACP-196 in Subjects With Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia
Study Start Date : January 2014
Estimated Primary Completion Date : January 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: acalabrutinib Drug: acalabrutinib


Outcome Measures
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Primary Outcome Measures :
  1. Determine the Maximum Tolerated Dose [ Time Frame: Cycle 1 (28 Days) ]

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

Inclusion Criteria:

  • Men and women ≥ 18 years of age with a confirmed diagnosis of CLL/SLL, which has relapsed after, or been refractory to, ≥ 2 previous treatments for CLL/SLL; however, subjects with 17p deletion are eligible if they have relapsed after, or been refractory to, 1 prior treatment for CLL/SLL.
  • Treatment Naive only: and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy.
  • Richter's Syndrome and Prolymphocytic Leukemia Transformation only: biopsy proven DLBCL Richter's transformation or prolymphocytic leukemia transformation.
  • Subjects have been diagnosed with measurable CLL/SLL.
  • Subjects have active disease meeting the IWCLL 2008 published criteria.
  • ECOG performance status of ≤ 2.
  • Agreement to use contraception during the study and for 90 days after the last dose of study drug if sexually active and able to bear children.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

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. Note: these cases must be discussed with the Medical Monitor.
  • 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, 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 left ventricular ejection fraction (LVEF) ≤ 40%.
  • 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).
  • Relapsed after, or refractory to, prior BTK inhibitor therapy.
  • Central nervous system (CNS) involvement by lymphoma
  • Grade ≥ 2 toxicity (other than alopecia) continuing from prior anticancer therapy including radiation.
  • 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.
  • Major surgery within 4 weeks before first dose of study drug.
  • ANC < 0.75 x 109/L or platelet count < 50 x 109/L unless there is bone marrow involvement.
  • 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) > 3.0 x ULN unless disease related.
  • Serum amylase > 1.5 x ULN or serum lipase > 1.5 x ULN.
  • 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 ms.
  • Cardiac troponin I or cardiac troponin T levels above the limit of normal as specified by the manufacturer.
  • Lactating or pregnant.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02029443


Locations
United States, District of Columbia
Washington, District of Columbia, United States
United States, Massachusetts
Boston, Massachusetts, United States, 02115
United States, New York
New Hyde Park, New York, United States
New York, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Texas
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Washington
Seattle, Washington, United States
Tacoma, Washington, United States
Italy
Milano, Italy
United Kingdom
Leeds, United Kingdom
London, United Kingdom, 00000
Oxford, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Study Director: Prista Charuworn, MD Acerta Pharma, LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02029443     History of Changes
Other Study ID Numbers: ACE-CL-001
First Posted: January 8, 2014    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016

Keywords provided by Acerta Pharma BV:
Bruton's tyrosine kinase inhibitor

Additional relevant MeSH terms:
Syndrome
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Prolymphocytic
Disease
Pathologic Processes
 Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell