Description:
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).
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).
Active, not recruiting
Phase 2
NCT ID: NCT02213926
ORG ID: ACE-LY-004
Mantle Cell Lymphoma (MCL)
Drug | Synonyms | Arms |
---|---|---|
ACP-196 | ACP-196 Regimen 1 |
The purpose of this study is to characterize the safety and efficacy profile of ACP-196 in
subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).
Name | Type | Description | Interventions |
---|---|---|---|
ACP-196 Regimen 1 | Experimental | ACP-196 Regimen 1 | ACP-196 |
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, 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
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Overall response rate (ORR) of ACP-196 in subjects with previously treated MCL.
Bruton tyrosine kinase inhibitor
Btk
Mantle Cell Lymphoma
MCL
ACP-196