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Trial record 25 of 53 for:    acalabrutinib

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

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ClinicalTrials.gov Identifier: NCT02180711
Recruitment Status : Recruiting
First Posted : July 3, 2014
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Acerta Pharma BV

Tracking Information
First Submitted Date  ICMJE June 30, 2014
First Posted Date  ICMJE July 3, 2014
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE February 2015
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2014)
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 ]
Number of participants who had experienced at least one treatment emergent AE
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02180711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Official Title  ICMJE An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Brief Summary

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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non Hodgkin Lymphoma
Intervention  ICMJE
  • Drug: acalabrutinib
    Other Name: ACP-196
  • Drug: rituximab (IV)
  • Drug: Lenalidomide
Study Arms  ICMJE
  • Experimental: Part 1: acalabrutinib Regimen 1
    acalabrutinib Regimen 1
    Intervention: Drug: acalabrutinib
  • Experimental: Part 1: acalabrutinib Regimen 2
    acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive subjects
    Interventions:
    • Drug: acalabrutinib
    • Drug: rituximab (IV)
  • Experimental: Part 2: acalabrutinib Regimen 1
    acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
    Intervention: Drug: acalabrutinib
  • Experimental: Part 2: acalabrutinib Regimen 2
    acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
    Interventions:
    • Drug: acalabrutinib
    • Drug: rituximab (IV)
  • Experimental: Part 3: acalabrutinib Regimen 1
    acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
    Interventions:
    • Drug: acalabrutinib
    • Drug: rituximab (IV)
    • Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2019)
80
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2014)
32
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Acerta Call center 1-888-292-9613 acertamc@dlss.com
Listed Location Countries  ICMJE United States
Removed Location Countries France,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT02180711
Other Study ID Numbers  ICMJE ACE-LY-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acerta Pharma BV
Study Sponsor  ICMJE Acerta Pharma BV
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Acerta Call center Acerta Pharma, LLC
PRS Account Acerta Pharma BV
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP