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A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

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ClinicalTrials.gov Identifier: NCT02717611
Recruitment Status : Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: ACP-196 (acalabrutinib) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
Study Start Date : January 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
Experimental: ACP-196 (acalabrutinib) Drug: ACP-196 (acalabrutinib)



Primary Outcome Measures :
  1. The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed/refractory CLL who are intolerant of ibrutinib therapy [ Time Frame: 36 cycles (each cycle is 28 days) up to 36 months ]


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
Criteria

Inclusion Criteria:

  1. Men and women ≥ 18 years of age.
  2. Prior diagnosis of CLL
  3. Must have received ≥ 1 prior therapy for CLL
  4. Intolerant of ibrutinib
  5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
  6. ECOG performance status of ≤ 2.

Exclusion Criteria:

  1. Ongoing AE attributed to ibrutinib therapy
  2. Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
  3. Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT-199)
  4. Prior malignancy (other than CLL), except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years.
  5. Significant cardiovascular disease such as uncontrolled or symptomatic untreated 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 QTc > 480 msec at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.

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 ClinicalTrials.gov identifier (NCT number): NCT02717611


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Locations
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United States, Arizona
Tucson, Arizona, United States, 85711
United States, California
Concord, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Santa Barbara, California, United States
Stanford, California, United States
Whittier, California, United States
United States, Colorado
Pueblo, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Tampa, Florida, United States
United States, Illinois
Chicago, Illinois, United States
Harvey, Illinois, United States
United States, Louisiana
Lake Charles, Louisiana, United States
United States, Montana
Billings, Montana, United States
United States, New York
Lake Success, New York, United States
New York, New York, United States
United States, Ohio
Canton, Ohio, United States
Columbus, Ohio, United States
United States, Oregon
Springfield, Oregon, United States
United States, Texas
Houston, Texas, United States
Sherman, Texas, United States
Tyler, Texas, United States
United States, Washington
Puget Sound, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
United States, Wisconsin
Milwaukee, Wisconsin, United States
Belgium
Antwerpen, Belgium
Brugge, Belgium
Brussels, Belgium
Gent, Belgium
Leper, Belgium
France
Bordeaux, France
Clermont, France
Marseille, France
Paris, France
Rennes Cedex, France
Vandoeuvre-les-Nancy, France
Israel
Haifa, Israel
Petah Tiqva, Israel
Spain
Barcelona, Spain
Madrid, Spain
Majadahonda, Spain
Pamplona, Spain
United Kingdom
Bournemouth, United Kingdom
Leeds, United Kingdom
Leiscester, United Kingdom
Manchester, United Kingdom
Withington, United Kingdom
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02717611     History of Changes
Other Study ID Numbers: ACE-CL-208
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Acerta Pharma BV:
Chronic Lymphocytic Leukemia
Ibrutinib Intolerant
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell