Clinical trial NCT02112526: Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL)
Keywords: 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
DLBCL
Lymphoma
B-Cell
Immunoproliferative Disorders
Immune System Diseases
Bruton's tyrosine kinase
Lead sponsor: Acerta Pharma BV
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
timeFrame: SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Secondary outcomes:
measure: Area Under the Plasma Concentration (AUC)
timeFrame: 1 Cycle (28 days)
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 1 Cycle (28 days)
measure: Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
timeFrame: 2 Cycles (1 cycle = 28 days) and at end of treatment
measure: Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
timeFrame: From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: New York
country: United States
facility: Research Site
state: New York
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Houston
country: United States
facility: Research Site
state: Texas
city: Leicester
country: United Kingdom
facility: Research Site
city: Plymouth
country: United Kingdom
facility: Research Site
Study officials:
affiliation: 1-877-240-9479; information.center@astrazeneca.com
name: AstraZeneca Clinical Trials
role: STUDY_DIRECTOR
References: