Clinical Trials /

Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

NCT02180711

Description:

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR. Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Related Conditions:
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
  • Official Title: An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: ACE-LY-003
  • NCT ID: NCT02180711

Conditions

  • Non Hodgkin Lymphoma

Interventions

DrugSynonymsArms
acalabrutinibACP-196Part 1: acalabrutinib Regimen 1
rituximab (IV)Part 1: acalabrutinib Regimen 2
LenalidomidePart 3: acalabrutinib Regimen 1

Purpose

Part 1: To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with R/R FL. Part 2: To characterize the activity of acalabrutinib alone or in combination with rituximab in subjects with R/R MZL, as measured by ORR. Part 3: To characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in subjects with R/R FL

Detailed Description

      An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects
      with B-cell Non-Hodgkin Lymphoma
    

Trial Arms

NameTypeDescriptionInterventions
Part 1: acalabrutinib Regimen 1Experimentalacalabrutinib Regimen 1
  • acalabrutinib
Part 1: acalabrutinib Regimen 2Experimentalacalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive subjects
  • acalabrutinib
  • rituximab (IV)
Part 2: acalabrutinib Regimen 1Experimentalacalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
  • acalabrutinib
Part 2: acalabrutinib Regimen 2Experimentalacalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
  • acalabrutinib
  • rituximab (IV)
Part 3: acalabrutinib Regimen 1Experimentalacalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
  • acalabrutinib
  • rituximab (IV)
  • Lenalidomide

Eligibility Criteria

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  Part 1: A confirmed diagnosis of FL Grade 1, 2, or 3a, which has relapsed after, or
             been refractory to ≥ 1 prior therapy for FL, or subjects who have not previously
             received systemic anticancer therapy for FL., and which requires treatment.

          -  Part 2:Histologically confirmed MZL including splenic, nodal, and extranodal sub-
             types

               1. Subjects with splenic MZL must have an additional measurable lesion, nodal or
                  extranodal, as described in inclusion criterion #4;

               2. Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be
                  Helicobacter pylori (HP)-negative

          -  Part 3: For subjects with FL: Pathologically confirmed diagnosis of FL Grade 1, 2, or
             3a, which has relapsed after, or been refractory to ≥ 1 prior therapy for FL and which
             requires treatment per National Cancer Institute or ESMO clinical practice guidelines.

          -  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 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 Qtc >480 msec

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory
             bowel disease, or partial or complete bowel obstruction.

          -  Breast feeding or pregnant
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of Participants With Treatment Emergent Adverse Events (AEs)
Time Frame:From first dose of study drug to within 30 days of last dose of study drug
Safety Issue:
Description:Number of participants who had experienced at least one treatment emergent AE

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Acerta Pharma BV

Trial Keywords

  • Bruton tyrosine kinase inhibitor
  • Btk
  • Follicular Lymphoma
  • FL
  • acalabrutinib
  • ACP-196
  • MZL
  • Marginal Zone Lymphoma

Last Updated

June 18, 2019