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

April 3, 2024 updated by: Acerta Pharma BV

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom, LE1 7RH
        • Research Site
      • Plymouth, United Kingdom, PL6 8DH
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Research Site
    • New York
      • New York, New York, United States, 10021
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 130 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acalabrutinib
Drug: Acalabrutinib
Other Names:
  • ACP-196

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Time Frame: 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.
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)
Time Frame: 1 Cycle (28 days)
To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
1 Cycle (28 days)
Maximum Observed Plasma Concentration (Cmax)
Time Frame: 1 Cycle (28 days)
To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
1 Cycle (28 days)
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
Time Frame: 2 Cycles (1 cycle = 28 days) and at end of treatment
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)
Time Frame: 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
From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acerta Pharma BV

Investigators

  • Study Director: AstraZeneca Clinical Trials, 1-877-240-9479; information.center@astrazeneca.com

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2014

Primary Completion (Actual)

June 30, 2020

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimated)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE-LY-002
  • 2014-001341-25 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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

IPD Sharing 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:

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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