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

Phase 1

Completed

• Conditions: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
• Interventions: Drug: Acalabrutinib

• Registration Number: NCT02112526
• Lead Sponsor: Acerta Pharma BV

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-11
• Study First Posted: 2014-04-14
• Study Start: 2014-08-07
• Results First Submitted: 2020-04-30
• Primary Completion: 2020-06-30
• Results First Submitted QC: 2020-07-14
• Results First Posted: 2020-07-29
• Study Completion: 2024-10-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acalabrutinib	Acalabrutinib	-

Primary Outcome Measures

Name	Time	Method
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.	SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.	Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax)	1 Cycle (28 days)	To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Area Under the Plasma Concentration (AUC)	1 Cycle (28 days)	To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)	2 Cycles (1 cycle = 28 days) and at end of treatment	To evaluate the concentration pharmacodynamic effects of acalabrutinib
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)	From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)	To evaluate the activity of acalabrutinib as measured by ORR

Trial Locations

Locations (1)

Research Site; 🇬🇧 Plymouth, United Kingdom