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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 : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE March 11, 2016
First Posted Date  ICMJE March 24, 2016
Last Update Posted Date January 29, 2021
Actual Study Start Date  ICMJE March 8, 2016
Actual Primary Completion Date October 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2021)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 18, 2016)
The overall response rate (ORR) at 36 cycles 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) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
Official Title  ICMJE A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: ACP-196 (acalabrutinib)
ACP-196 100 mg to be administered orally (PO) twice a day BID.
Other Name: Acalabrutinib
Study Arms  ICMJE Experimental: ACP-196 (acalabrutinib)
ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID
Intervention: Drug: ACP-196 (acalabrutinib)
Publications * Mato AR, Nabhan C, Barr PM, Ujjani CS, Hill BT, Lamanna N, Skarbnik AP, Howlett C, Pu JJ, Sehgal AR, Strelec LE, Vandegrift A, Fitzpatrick DM, Zent CS, Feldman T, Goy A, Claxton DF, Bachow SH, Kaur G, Svoboda J, Nasta SD, Porter D, Landsburg DJ, Schuster SJ, Cheson BD, Kiselev P, Evens AM. Outcomes of CLL patients treated with sequential kinase inhibitor therapy: a real world experience. Blood. 2016 Nov 3;128(18):2199-2205. Epub 2016 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 20, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2016)
80
Estimated Study Completion Date  ICMJE December 31, 2025
Actual Primary Completion Date October 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Israel,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717611
Other Study ID Numbers  ICMJE ACE-CL-208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Acerta Clinical Trials 1-888-292-9613; acertamc@dlss.com
PRS Account Acerta Pharma BV
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP