Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02717611
Recruitment Status : Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : January 29, 2021
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

Detailed Description:
A Multicenter, Open-Label, Phase 2 study evaluating the efficacy and safety of Acalabrutinib in subjects with relapsed/refractory CLL (N=60) who are intolerant of ibrutinib therapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
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
Actual Study Start Date : March 8, 2016
Actual Primary Completion Date : October 16, 2020
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACP-196 (acalabrutinib)
ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID
Drug: ACP-196 (acalabrutinib)
ACP-196 100 mg to be administered orally (PO) twice a day BID.
Other Name: Acalabrutinib




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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. Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
  6. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
  7. 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.
  6. Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
  7. Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
  8. CNS involvement by CLL or related Richter's transformation.
  9. Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
  10. Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
  11. History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.
  12. History of bleeding diathesis.
  13. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
  14. Major surgical procedure within 28 days of first dose of study drug.
  15. Requires treatment with a strong CYP3A inhibitor

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


Locations
Layout table for location information
United States, Arizona
Research Site
Tucson, Arizona, United States, 85704
United States, California
Research Site
Concord, California, United States, 94520
Research Site
La Jolla, California, United States, 92093
Research Site
Palo Alto, California, United States, 94304
United States, District of Columbia
Research Site
Washington, District of Columbia, United States, 20007
United States, Illinois
Research Site
Chicago, Illinois, United States, 60611
United States, New York
Research Site
Lake Success, New York, United States, 11042
Research Site
New York, New York, United States, 10021
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site
Nashville, Tennessee, United States, 37203
United States, Texas
Research Site
Houston, Texas, United States, 77030
Research Site
Sherman, Texas, United States, USA
United States, Washington
Research Site
Seattle, Washington, United States, 98108
Research Site
Seattle, Washington, United States, 98122
Research Site
Spokane, Washington, United States, 99208
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53226
Belgium
Research Site
Brugge, Belgium, 8000
France
Research Site
Bordeaux, France, 33076, FR
Israel
Research Site
Haifa, Israel, 31000
Spain
Research Site
Madrid, Spain, 28006
United Kingdom
Research Site
Bournemouth, United Kingdom, BH7 7DW
Research Site
Leeds, United Kingdom, LS9 7TF
Research Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Acerta Pharma BV
Investigators
Layout table for investigator information
Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02717611    
Other Study ID Numbers: ACE-CL-208
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

Layout table for additional information
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:
Layout table for MeSH terms
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