Clinical Trials /

An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma

NCT02213926

Description:

The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Related Conditions:
  • Anaplastic Large Cell Lymphoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02213926

Trial Eligibility

Document

Title

  • Brief Title: An Open-label, Phase 2 Study of ACP-196 (Acalabrutinib) in Subjects With Mantle Cell Lymphoma
  • Official Title: An Open-label, Phase 2 Study of ACP-196 in Subjects With Mantle Cell Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: ACE-LY-004
  • NCT ID: NCT02213926

Conditions

  • Mantle Cell Lymphoma (MCL)

Interventions

DrugSynonymsArms
ACP-196 (acalabrutinib)ACP-196 (acalabrutinib) Regimen 1

Purpose

The purpose of this study is to characterize the safety and efficacy profile of ACP-196 (acalabrutinib) in subjects with relapsed or refractory Mantle Cell Lymphoma (MCL).

Detailed Description

      This clinical trial is a Phase 2, multicenter, (approximately 70 global centers), open-label
      study in subjects with histologically documented MCL, who have relapsed after, or were
      refractory to, ≥ 1 (but not > 5) prior treatment regimens. Subjects will be enrolled and will
      take 100 mg of acalabrutinib twice per day (BID) in repeated 28-day cycles.

      Treatment with acalabrutinib may be continued until disease progression or an unacceptable
      drug-related toxicity occurs. Dose modification provisions are provided in the study
      protocol.

      All subjects will have hematology, chemistry, and urinalysis safety panels done at screening.
      Once dosing commences (Day 1), all subjects will be evaluated for safety, including serum
      chemistry and hematology, once weekly for the first 4 weeks, every 2 weeks in Cycle 2, every
      4 weeks in Cycles 3 to 12, and every 24 weeks thereafter. PK/PD testing will be done in
      Cycles 1 and 2. Tumor assessments will be completed at 8- to 24-week intervals during the
      trial.

Trial Arms

NameTypeDescriptionInterventions
ACP-196 (acalabrutinib) Regimen 1ExperimentalACP-196 (acalabrutinib) Regimen 1
  • ACP-196 (acalabrutinib)

Eligibility Criteria

        Inclusion criteria:

          -  Men and women ≥ 18 years of age.

          -  Pathologically confirmed MCL, with documentation of monoclonal B cells that have a
             chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.

          -  Agreement to use contraception during the study and for 30 days after the last dose of
             study drugs if sexually active and able to bear or beget children.

        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 ACP-196 (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 corrected QT interval (QTc) > 480 msec.

          -  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
Maximum Eligible Age:130 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Response Rate (ORR) of ACP-196 (Acalabrutinib) in Subjects With Previously Treated MCL.
Time Frame:Participants will be followed every 28 days or until progression of disease or start of another anti-cancer treatment for at least 1 year
Safety Issue:
Description:The overall response rate (ORR) is defined as the proportion of subjects achieving either a partial remission (response) (PR) or complete response (CR) according to the Lugano Classification for NHL (Cheson 2014) as assessed by investigators, where SD stands for Stable Disease, PD for Progressive Disease and NE for Not Evaluable.

Details

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

Trial Keywords

  • Bruton tyrosine kinase inhibitor
  • Btk
  • Mantle Cell Lymphoma
  • MCL
  • ACP-196
  • Acalabrutinib
  • ACE-LY-004
  • Calquence

Last Updated

July 22, 2021