Acalabrutinib (ACP-196), a Btk Inhibitor, for Treatment of de Novo Activated B-cell (ABC) Subtype of Diffuse Large B-Cell Lymphoma
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
2 other identifiers
interventional
21
2 countries
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2014
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2014
CompletedFirst Posted
Study publicly available on registry
April 14, 2014
CompletedStudy Start
First participant enrolled
August 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedResults Posted
Study results publicly available
July 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 4, 2024
CompletedDecember 20, 2024
November 1, 2024
5.9 years
April 10, 2014
April 30, 2020
November 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Area Under the Plasma Concentration (AUC)
1 Cycle (28 days)
Maximum Observed Plasma Concentration (Cmax)
1 Cycle (28 days)
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
2 Cycles (1 cycle = 28 days) and at end of treatment
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)
Study Arms (1)
Acalabrutinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Men and women ≥ 18 years of age.
- Pathologically confirmed de novo ABC DLBCL
- Relapsed or refractory disease
- Subjects must have ≥ 1 measurable disease sites
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acerta Pharma BVlead
Study Sites (7)
Research Site
Los Angeles, California, 90095, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
New York, New York, 10021, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Leicester, LE1 7RH, United Kingdom
Research Site
Plymouth, PL6 8DH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Acerta Pharma LLC
Study Officials
- STUDY DIRECTOR
AstraZeneca Clinical Trials
1-877-240-9479; information.center@astrazeneca.com
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2014
First Posted
April 14, 2014
Study Start
August 7, 2014
Primary Completion
June 30, 2020
Study Completion
October 4, 2024
Last Updated
December 20, 2024
Results First Posted
July 29, 2020
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. URL:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: htttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.