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Study of Acalabrutinib Alone or in Combination With Rituximab in Indolent B-cell Non-Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT02180711
Recruitment Status : Recruiting
First Posted : July 3, 2014
Last Update Posted : March 5, 2018
Sponsor:
Collaborator:
Acerta Pharma, LLC
Information provided by (Responsible Party):
Acerta Pharma BV

Brief Summary:
To characterize the safety profile of acalabrutinib alone or in combination with rituximab in subjects with Indolent B-cell Non-Hodgkin Lymphoma

Condition or disease Intervention/treatment Phase
Follicular Lymphoma (FL) Drug: acalabrutinib Drug: rituximab (IV) Phase 1 Phase 2

Detailed Description:
An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination with Rituximab in Subjects with Indolent B cell Non-Hodgkin Lymphoma - Marginal Zone Lymphoma

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Phase 1b/2 Study of Acalabrutinib Alone or in Combination With Rituximab in Subjects With Indolent B Cell Non-Hodgkin Lymphoma
Actual Study Start Date : February 2015
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : July 2022


Arm Intervention/treatment
Experimental: acalabrutinib Regimen 1
acalabrutinib Regimen 1
Drug: acalabrutinib
Other Name: ACP-196

Experimental: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive subjects
Drug: acalabrutinib
Other Name: ACP-196

Drug: rituximab (IV)



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

    • 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

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 ClinicalTrials.gov identifier (NCT number): NCT02180711


Contacts
Contact: Call center 1-888-292-9613 acertamc@dlss.com

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Lacolle Peters    626-218-4632    lapeters@coh.org   
Principal Investigator: Robert Chen, MD         
Innovative Clinical Research Completed
Whittier, California, United States, 90603
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Burge Tonya    312-942-3309    tonya_m_burge@rush.edu   
Principal Investigator: Parameswaran Venugopal, MD         
University of Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Jennifer Madden    773-834-4574    jmadden@medicine.bsd.uchicago.edu   
Principal Investigator: Sonali Smith, MD         
United States, Kentucky
Norton Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Dana Haycraft       dana.haycraft@nortonhealthcare.org   
Contact: Heather Woolridge       heather.woolridge@nortonhealthcare.org   
Principal Investigator: Don Stevens, MD         
United States, Michigan
University of Michigan, Comprehensive Cancer Center Active, not recruiting
Ann Arbor, Michigan, United States, 48109
United States, New York
Clinical Research Alliance Recruiting
Lake Success, New York, United States, 11042
Contact: Colleen Kats       ckats@researchcra.com   
Contact: Judith Lovecchio       jlovecchio@researchcra.com   
Principal Investigator: Morton Coleman, MD         
Weill Cornell Medical College Active, not recruiting
New York, New York, United States, 10065
United States, Ohio
The Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Cynthia Jenkins, RN, BSN    614-366-0855    cynthia.jenkins@osumc.edu   
Contact: Beth Christian, MD       Beth.Christian@osumc.edu   
Principal Investigator: Beth Christian, MD         
United States, Texas
MD Anderson Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute Not yet recruiting
Salt Lake City, Utah, United States, 84112
Contact: Anna Frye       anna.frye@hci.utah.edu   
Contact: Lindsay Carpenter       lindsay.carpenter@hci.utah.edu   
Principal Investigator: Deborah Stephens, MD         
Sponsors and Collaborators
Acerta Pharma BV
Acerta Pharma, LLC
Investigators
Study Director: Dorothy Nguyen, MD. Acerta Pharma, LLC

Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02180711     History of Changes
Other Study ID Numbers: ACE-LY-003
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Acerta Pharma BV:
Bruton tyrosine kinase inhibitor
Btk
Follicular Lymphoma
FL
acalabrutinib
ACP-196
MZL
Marginal Zone Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents