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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112526
Recruitment Status : Active, not recruiting
First Posted : April 14, 2014
Results First Posted : July 29, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

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).

Condition or disease Intervention/treatment Phase
Activated B-cell Diffuse Large B-Cell Lymphoma (ABC DLBCL) Drug: Acalabrutinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 7, 2014
Actual Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2025


Arm Intervention/treatment
Experimental: Acalabrutinib Drug: Acalabrutinib
Other Name: ACP-196




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Area Under the Plasma Concentration (AUC) [ Time Frame: 1 Cycle (28 days) ]
    To Characterize the Pharmacokinetic parameter AUC of acalabrutinib

  2. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 1 Cycle (28 days) ]
    To Characterize the Pharmacokinetic parameter Cmax of acalabrutinib

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112526


Locations
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United States, California
Research Site
Los Angeles, California, United States, 90095
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30322
United States, New York
Research Site
New York, New York, United States, 10021
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, Texas
Research Site
Houston, Texas, United States, 77030
United Kingdom
Research Site
Devon, United Kingdom, PL6 8DH
Research Site
Leicester, United Kingdom, LE1 7RH
Sponsors and Collaborators
Acerta Pharma BV
Investigators
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Study Director: Acerta Clinical Trials 1-888-292-9613;acertamc@dlss.com
  Study Documents (Full-Text)

Documents provided by Acerta Pharma BV:
Study Protocol  [PDF] January 13, 2016
Statistical Analysis Plan  [PDF] March 20, 2018

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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02112526    
Other Study ID Numbers: ACE-LY-002
First Posted: April 14, 2014    Key Record Dates
Results First Posted: July 29, 2020
Last Update Posted: November 24, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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:

URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by Acerta Pharma BV:
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin