Clinical Trials /

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

NCT02337829

Description:

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

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Acalabrutinib in Patients With Relapsed/Refractory and Treatment naïve Deletion 17p CLL/SLL
  • 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.

Clinical Trial IDs

  • ORG STUDY ID: 15-H-0016
  • NCT ID: NCT02337829

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma

Interventions

DrugSynonymsArms
Acalabrutinib (Arm A)ACP-196Arm A
Acalabrutinib (Arm B)ACP-196Arm A

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalSubjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
  • Acalabrutinib (Arm A)
  • Acalabrutinib (Arm B)
Arm BExperimentalSubjects will be randomized to receive 1 of 2 dosing regimens: 1) acalabrutinib, dose A once daily; or 2) acalabrutinib, dose B twice daily.
  • Acalabrutinib (Arm A)
  • Acalabrutinib (Arm B)

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Response Based on Overall Response Rate
Time Frame:Cycle 1 (28 Days) to 6 months
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Acerta Pharma BV

Trial Keywords

  • Relapsed/refractory CLL
  • Btk
  • Leukemia
  • Lymphocytic
  • Lymphoma
  • Chronic Lymphocytic Leukemia (CLL)
  • Small Lymphocytic Lymphoma (SLL)
  • ACP-196
  • Acalabrutinib
  • Treatment naive CLL
  • 17p deletion
  • TP53 mutation
  • NOTCH1 mutation

Last Updated

August 18, 2021