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

Study Overview
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Brief Summary
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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).

Official Title
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An Open-label, Phase 1b Study of ACP 196 in Subjects With Relapsed or Refractory de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma

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

Intervention / Treatment
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* Drug: Acalabrutinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acalabrutinib<br> | Drug: Acalabrutinib<br> <br> * Other names: ACP-196;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DLBCL, de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma, Diffuse Large B-Cell Lymphoma, de Novo Activated B-cell (ABC), de Novo Activated B-cell, ABC DLBCL, Lymphoma, B-Cell, Immunoproliferative Disorders, Immune System Diseases, Bruton's tyrosine kinase