Status:
ACTIVE_NOT_RECRUITING
An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
Lead Sponsor:
Acerta Pharma BV
Conditions:
Mantle Cell Lymphoma (MCL)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
Detailed Description
This clinical trial is a Phase 2, multicenter, (approximately 70 global centers), open-label study in subjects with histologically documented MCL, who have relapsed after, or were refractory to, ≥ 1 (...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 2 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2026
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT02213926
Start Date
March 2 2015
End Date
September 6 2026
Last Update
November 25 2025
Active Locations (58)
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1
Research Site
Tampa, Florida, United States, 33612
2
Research Site
Chicago, Illinois, United States, 60612
3
Research Site
Niles, Illinois, United States, 60714
4
Research Site
Peoria, Illinois, United States, 61615