An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
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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: NCT02213926 |
Recruitment Status :
Active, not recruiting
First Posted : August 12, 2014
Results First Posted : October 19, 2018
Last Update Posted : July 10, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Mantle Cell Lymphoma (MCL) | Drug: ACP-196 (acalabrutinib) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 124 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma |
Actual Study Start Date : | March 2015 |
Actual Primary Completion Date : | February 2017 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: ACP-196 (acalabrutinib) Regimen 1
ACP-196 (acalabrutinib) Regimen 1
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Drug: ACP-196 (acalabrutinib) |
- Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL. [ Time Frame: Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year ]The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Men and women ≥ 18 years of age.
- Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
- Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.
Exclusion criteria:
- 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 ACP-196 (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 corrected QT interval (QTc) > 480 msec.
- 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.
- Breast feeding or pregnant

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): NCT02213926
United States, New York | |
New York, New York, United States | |
United Kingdom | |
Plymouth, United Kingdom |
Study Director: | Acerta Pharma | 1-888-292-9613 |
Documents provided by Acerta Pharma BV:
Responsible Party: | Acerta Pharma BV |
ClinicalTrials.gov Identifier: | NCT02213926 |
Other Study ID Numbers: |
ACE-LY-004 |
First Posted: | August 12, 2014 Key Record Dates |
Results First Posted: | October 19, 2018 |
Last Update Posted: | July 10, 2019 |
Last Verified: | June 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Bruton tyrosine kinase inhibitor Btk Mantle Cell Lymphoma MCL |
ACP-196 Acalabrutinib ACE-LY-004 Calquence |
Lymphoma Lymphoma, Mantle-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |