A Study of ACP-196 (Acalabrutinib) in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
A Phase 2 Study of the Efficacy and Safety of ACP-196 in Subjects With Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy
2 other identifiers
interventional
60
6 countries
23
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2016
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 8, 2016
CompletedFirst Submitted
Initial submission to the registry
March 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2020
CompletedResults Posted
Study results publicly available
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 6, 2026
ExpectedMarch 25, 2026
March 1, 2026
4.6 years
March 11, 2016
October 4, 2021
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Overall Response Rate (ORR) of ACP-196 (Acalabrutinib)
The overall response rate (ORR) of ACP-196 (acalabrutinib) in subjects with relapsed / refractory CLL who are intolerant of ibrutinib therapy. ORR is defined as the proportion of subjects achieving a best overall response (BOR) of either complete remission (CR), complete remission with incomplete bone marrow recovery (CRi), nodular partial remission (nPR), or partial remission (PR) at or before initiation of subsequent anticancer therapy. ORR will be analyzed per investigator's assessment.
From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to approximately 4 years and 7 months). 1 cycle = 28 days
Secondary Outcomes (4)
Progression-Free Survival
From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).
Duration of Response
From the date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Time-to-Next Treatment
From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
Overall Survival
From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years).
Study Arms (1)
ACP-196 (acalabrutinib)
EXPERIMENTALACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID
Interventions
ACP-196 100 mg to be administered orally (PO) twice a day BID.
Eligibility Criteria
You may qualify if:
- Men and women ≥ 18 years of age.
- Prior diagnosis of CLL
- Must have received ≥ 1 prior therapy for CLL
- Intolerant of ibrutinib
- Documented disease progression after stopping ibrutinib therapy as defined by the IWCLL 2008 criteria
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty.
- ECOG performance status of ≤ 2.
You may not qualify if:
- Ongoing AE attributed to ibrutinib therapy
- Treatment with systemic anticancer therapy for CLL is prohibited between discontinuation of ibrutinib and enrollment on this trial.
- Prior exposure to a BCL-2 inhibitor (eg, venetoclax/ABT- 199)
- 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.
- 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.
- 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.
- Evidence of active Richter's transformation or any evidence of disease progression on ibrutinib therapy or any BTK inhibitor.
- CNS involvement by CLL or related Richter's transformation.
- Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection.
- Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
- History of stroke or intracranial hemorrhage within 2 months before the first dose of study drug.
- History of bleeding diathesis.
- Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening.
- Major surgical procedure within 28 days of first dose of study drug.
- Requires treatment with a strong CYP3A inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
Study Sites (23)
Research Site
Tucson, Arizona, 85704, United States
Research Site
Concord, California, 94520, United States
Research Site
La Jolla, California, 92093, United States
Research Site
Palo Alto, California, 94304, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Chicago, Illinois, 60611, United States
Research Site
Lake Success, New York, 11042, United States
Research Site
New York, New York, 10021, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Nashville, Tennessee, 37203, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Sherman, Texas, USA, United States
Research Site
Seattle, Washington, 98108, United States
Research Site
Seattle, Washington, 98122, United States
Research Site
Spokane, Washington, 99208, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Research Site
Bruges, 8000, Belgium
Research Site
Bordeaux, 33076, FR, France
Research Site
Haifa, 31000, Israel
Research Site
Madrid, 28006, Spain
Research Site
Bournemouth, BH7 7DW, United Kingdom
Research Site
Leeds, LS9 7TF, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
Related Publications (2)
Rogers KA, Thompson PA, Allan JN, Coleman M, Sharman JP, Cheson BD, Jones D, Izumi R, Frigault MM, Quah C, Raman RK, Patel P, Wang MH, Kipps TJ. Phase II study of acalabrutinib in ibrutinib-intolerant patients with relapsed/refractory chronic lymphocytic leukemia. Haematologica. 2021 Sep 1;106(9):2364-2373. doi: 10.3324/haematol.2020.272500.
PMID: 33730844DERIVEDMato 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. doi: 10.1182/blood-2016-05-716977. Epub 2016 Sep 6.
PMID: 27601462DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- Acerta Pharma
Study Officials
- STUDY DIRECTOR
Acerta Clinical Trials
1-888-292-9613; acertamc@dlss.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 11, 2016
First Posted
March 24, 2016
Study Start
March 8, 2016
Primary Completion
October 16, 2020
Study Completion (Estimated)
June 6, 2026
Last Updated
March 25, 2026
Results First Posted
February 9, 2022
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, 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.
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.