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

Primary Purpose

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

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Acalabrutinib
Sponsored by
Acerta Pharma BV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) focused on measuring 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

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acalabrutinib

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Area Under the Plasma Concentration (AUC)
To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Maximum Observed Plasma Concentration (Cmax)
To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
To evaluate the concentration pharmacodynamic effects of acalabrutinib
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
To evaluate the activity of acalabrutinib as measured by ORR

Full Information

First Posted
April 10, 2014
Last Updated
September 20, 2023
Sponsor
Acerta Pharma BV
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1. Study Identification

Unique Protocol Identification Number
NCT02112526
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 7, 2014 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acerta Pharma BV

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acalabrutinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Acalabrutinib
Other Intervention Name(s)
ACP-196
Primary Outcome Measure Information:
Title
Safety Profile of Acalabrutinib in Subjects With Relapsed or Refractory ABC DLBCL.
Description
Safety assessments included SAEs TEAEs, including AEs leading to discontinuation of study drug or dose reduction.
Time Frame
SAEs collected from time of consent; TEAEs beginning after first dose and continuing through 30 days (+/- 7 days) after last dose.
Secondary Outcome Measure Information:
Title
Area Under the Plasma Concentration (AUC)
Description
To Characterize the Pharmacokinetic parameter AUC of acalabrutinib
Time Frame
1 Cycle (28 days)
Title
Maximum Observed Plasma Concentration (Cmax)
Description
To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib
Time Frame
1 Cycle (28 days)
Title
Evaluate Pharmacodynamic (PD) Effects (Done at US Sites Only)
Description
To evaluate the concentration pharmacodynamic effects of acalabrutinib
Time Frame
2 Cycles (1 cycle = 28 days) and at end of treatment
Title
Evaluate Activity of Acalabrutinib as Measured by Overall Response Rate (ORR)
Description
To evaluate the activity of acalabrutinib as measured by ORR
Time Frame
From enrollment to the date of disease progression, assessed up to Cycle 48 (1 cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Clinical Trials
Organizational Affiliation
1-877-240-9479; information.center@astrazeneca.com
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE1 7RH
Country
United Kingdom
Facility Name
Research Site
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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:
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-LY-002&amp;attachmentIdentifier=a4c264ed-fa39-4838-ab81-34e825c02b50&amp;fileName=ACE-LY-002_Protocol_Amendment_V4_dated_16Mar2020-redact.pdf&amp;versionIdentifier=
Description
Related Info
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=ACE-LY-002&amp;attachmentIdentifier=679c0d48-ae9f-49dd-af1f-a404914a80d9&amp;fileName=ACE-LY-002_Final_Safety_Report_CSR_Synopsis_Ed_2_dated_14Nov2018-redact.pdf&amp;versionIdentifier=
Description
Related Info

Learn more about this trial

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

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