Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

Acerta Pharma

Status and phase: Completed; Phase 1

Conditions: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)

Treatments: Drug: Acalabrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02112526

ACE-LY-002

2014-001341-25 (EudraCT Number)

Details and patient eligibility

About

To characterize the safety profile of acalabrutinib in subjects with relapsed or refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma (DLBCL).

Enrollment: 21 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women ≥ 18 years of age.
• Pathologically confirmed de novo ABC DLBCL
• Relapsed or refractory disease
• Subjects must have ≥ 1 measurable disease sites

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 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 LVEF < 50%
• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Acalabrutinib

Experimental group

Treatment:

Drug: Acalabrutinib