Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL

February 16, 2024 updated by: Acerta Pharma BV

A Phase II Study Using ACP-196 (Acalabrutinib) in Patients With Relapsed/Refractory and Treatment-naïve Deletion 17p CLL/SLL: Pharmacodynamic Assessment of BTK Inhibition and Antitumor Response.

This study is to determine the response to acalabrutinib in patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

To investigate the safety and efficacy of acalabrutinib for patients with CLL/SLL that have relapsed/refractory disease or treatment naive deletion 17p.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2

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 States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men and women 18 years of age and older with histologically confirmed disease.

  • Active disease as defined by at least one of the following (IWCLL consensus criteria):

    • Weight loss ≥10% within the previous 6 months
    • Extreme fatigue
    • Fevers of greater than 100.5ºF for ≥2 weeks without evidence of infection
    • Night sweats for more than one month without evidence of infection
    • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
    • Massive or progressive splenomegaly
    • Massive nodes or clusters or progressive lymphadenopathy
    • Progressive lymphocytosis with an increase of >50% over a 2 month period, or an anticipated doubling time of less than 6 months
    • Compensated autoimmune hemolysis
  • Relapsed/Refractory CLL or treatment naïve CLL patients with 17p deletion, TP53 mutation, or NOTCH1 mutation
  • Agreement to use acceptable methods of contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear or beget children.
  • Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty and serial biopsies.
  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations).

Exclusion Criteria:

  • Radiotherapy, radioimmunotherapy, biological therapy, chemotherapy, or investigational products in the last 4 weeks.
  • Richter's transformation. Autoimmune hemolytic anemia or thrombocytopenia requiring steroid therapy. Impaired hepatic function

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A
Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
Drug: Acalabrutinib (Arm A)
  • A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
  • A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
  • A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
  • A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z
Other Names:
  • ACP-196
Drug: Acalabrutinib (Arm B)

B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;

• B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.

Other Names:
  • ACP-196
Experimental: Arm B
Subjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
Drug: Acalabrutinib (Arm A)
  • A1a) acalabrutinib, dose A daily: biopsy (T) schedule W;
  • A1b) acalabrutinib, dose A daily: biopsy (T) schedule V.
  • A2a) acalabrutinib, dose B q 12 hours: biopsy (T) schedule Y;
  • A2b) acalabrutinib, dose B q 12 hours; biopsy (T) schedule Z
Other Names:
  • ACP-196
Drug: Acalabrutinib (Arm B)

B1c) acalabrutinib, dose A daily: biopsy (U) schedule W;

• B2c) acalabrutinib, dose B q12 hours: biopsy (U)) schedule Y.

Other Names:
  • ACP-196

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Based on Overall Response Rate
Time Frame: Cycle 1 (28 Days) to 6 months
The best response to treatment was determined according to International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Overall response rate (ORR) was the proportion of subjects who achieved complete response (CR), CR with incomplete marrow recovery (CRi), or partial response (PR) while on treatment before the initiation of new anti-cancer therapy or stem cell transplant.
Cycle 1 (28 Days) to 6 months

Collaborators and Investigators

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

Sponsor

Acerta Pharma BV

Collaborators

National Institutes of Health (NIH)

Investigators

  • Study Director: AstraZeneca Clinical Study Information Center, 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.

General Publications

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)

January 12, 2015

Primary Completion (Actual)

June 26, 2020

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

November 19, 2014

First Submitted That Met QC Criteria

January 9, 2015

First Posted (Estimated)

January 14, 2015

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-H-0016

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:

https://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 rerefer 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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