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

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. Identifier: NCT02337829
Recruitment Status : Active, not recruiting
First Posted : January 14, 2015
Last Update Posted : May 6, 2021
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Acerta Pharma BV

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

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Acalabrutinib (Arm A) Drug: Acalabrutinib (Arm B) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : January 12, 2015
Actual Primary Completion Date : June 26, 2020
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Experimental: Arm A
to undergo superficial lymph node biopsies
Drug: Acalabrutinib (Arm A)
Patients undergo lymph node biopsies
Other Name: ACP-196

Drug: Acalabrutinib (Arm B)
Patients undergo bone marrow biopsies
Other Name: ACP-196

Experimental: Arm B
to undergo bone marrow biopsies
Drug: Acalabrutinib (Arm A)
Patients undergo lymph node biopsies
Other Name: ACP-196

Drug: Acalabrutinib (Arm B)
Patients undergo bone marrow biopsies
Other Name: ACP-196

Primary Outcome Measures :
  1. Response based on overall response rate [ Time Frame: Cycle 1 (28 Days) to 6 months ]
    The best response to treatment will be determined according to IWCLL 2008 criteria incorporating 2012 and 2013 clarifications pertaining to subjects treated with kinase inhibitors. Response includes CR, PR, and PRL.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02337829

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United States, Maryland
Research Site
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Acerta Pharma BV
National Institutes of Health (NIH)
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Study Director: AstraZeneca Clinical Study Information Center 1-877-240-9479 -
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Acerta Pharma BV Identifier: NCT02337829    
Other Study ID Numbers: 15-H-0016
First Posted: January 14, 2015    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: April 2021
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: 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 rerefer to our disclosure commitment at
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
Keywords provided by Acerta Pharma BV:
Relapsed/refractory CLL
Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Lymphoma (SLL)
Treatment naive CLL
17p deletion
TP53 mutation
NOTCH1 mutation
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell