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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02180711
Recruitment Status : Active, not recruiting
First Posted : July 3, 2014
Last Update Posted : March 2, 2023
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Acerta Pharma BV

Study Description
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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


Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma Drug: acalabrutinib Drug: rituximab (IV) Drug: Lenalidomide Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: N/A
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 Therapy in Subjects With B-cell Non-Hodgkin Lymphoma
Actual Study Start Date : December 29, 2014
Estimated Primary Completion Date : August 25, 2023
Estimated Study Completion Date : August 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
 Drug: acalabrutinib
Other Name: ACP-196
Experimental: Part 1: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
 Drug: acalabrutinib
Other Name: ACP-196

Drug: rituximab (IV)
Experimental: Part 2: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
 Drug: acalabrutinib
Other Name: ACP-196
Experimental: Part 2: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
 Drug: acalabrutinib
Other Name: ACP-196

Drug: rituximab (IV)
Experimental: Part 3: acalabrutinib Regimen 1
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
 Drug: acalabrutinib
Other Name: ACP-196

Drug: rituximab (IV)
Drug: Lenalidomide


Outcome Measures
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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


Eligibility Criteria
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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: For subject with relapsed or refractory MZL:

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
Contacts and Locations
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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


Locations
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United States, Arizona
Research Site
Tucson, Arizona, United States, 85719
United States, California
Research Site
Downey, California, United States, 90241
Research Site
Duarte, California, United States, 91010
Research Site
Fountain Valley, California, United States, 92708
Research Site
Santa Monica, California, United States, 90404
United States, Florida
Research Site
Coral Gables FL, Florida, United States, 33146
United States, Illinois
Research Site
Chicago, Illinois, United States, 60611
Research Site
Chicago, Illinois, United States, 60612
Research Site
Chicago, Illinois, United States, 60637
United States, Kentucky
Research Site
Louisville, Kentucky, United States, 40207
United States, Louisiana
Research Site
New Orleans, Louisiana, United States, 70112
United States, Michigan
Research Site
Ann Arbor, Michigan, United States, 48109
United States, New Jersey
Research Site
Morristown, New Jersey, United States, 07960
United States, New York
Research Site
Hawthorne, New York, United States, 10532
Research Site
Lake Success, New York, United States, 11042
Research Site
New York, New York, United States, 10021
Research Site
Syracuse, New York, United States, 13210
United States, Ohio
Research Site
Columbus, Ohio, United States, 43210
United States, South Carolina
Research Site
Greenville, South Carolina, United States, 29615
United States, Texas
Research Site
Dallas, Texas, United States, 75235
Research Site
Houston, Texas, United States, 77030
Research Site
San Antonio, Texas, United States, 78217
Research Site
Temple, Texas, United States, 76508
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84112
United States, Washington
Research Site
Spokane, Washington, United States, 99208
United States, Wisconsin
Research Site
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Research Site
Edmonton, Alberta, Canada, t6G1Z2
Canada, Ontario
Research Site
London, Ontario, Canada, N6A 5W9
Research Site
Toronto, Ontario, Canada, M5G 2M9
Italy
Research Site
Bologna, Italy, 40138
Research Site
Milano, Italy, 20132
Research Site
Palermo, Italy, 90146
Sponsors and Collaborators
Acerta Pharma BV
AstraZeneca
More Information
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Responsible Party: Acerta Pharma BV
ClinicalTrials.gov Identifier: NCT02180711    
Other Study ID Numbers: ACE-LY-003
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: February 2023
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:
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Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Lenalidomide
 Acalabrutinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors