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

September 30, 2025 updated by: Acerta Pharma BV

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, t6G1Z2
        • Research Site
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Research Site
      • Milan, Italy, 20132
        • Research Site
      • Palermo, Italy, 90146
        • Research Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Research Site
    • California
      • 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
        • Research Site
    • Florida
      • Coral Gables FL, Florida, United States, 33146
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
      • Chicago, Illinois, United States, 60637
        • Research Site
      • Chicago, Illinois, United States, 60611
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Research Site
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Research Site
    • New York
      • 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
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Research Site
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Research Site
    • Texas
      • 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
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99208
        • Research Site
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects
Drug: acalabrutinib
Other Names:
  • ACP-196
Experimental: Part 1: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects
Drug: acalabrutinib
Other Names:
  • ACP-196
Drug: rituximab (IV)
Experimental: Part 2: acalabrutinib Regimen 1
acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects
Drug: acalabrutinib
Other Names:
  • ACP-196
Experimental: Part 2: acalabrutinib Regimen 2
acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects
Drug: acalabrutinib
Other Names:
  • ACP-196
Drug: rituximab (IV)
Experimental: Part 3: acalabrutinib Regimen 1
acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects
Drug: Lenalidomide
Drug: acalabrutinib
Other Names:
  • ACP-196
Drug: rituximab (IV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part 1: Incidence of Treatment-emergent Adverse Events.
Time Frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
Treatment-emergent adverse events were used to characterize the safety profile of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory follicular lymphoma (R/R FL).
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 80.7 months (the maximum participant's time on this study).
Part 2: Investigator Assessed Objective Response Rate (ORR) According to the Lugano Classification for Non-Hodgkin Lymphoma (NHL).
Time Frame: Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
The objective response rate (ORR) is used to characterize the activity of acalabrutinib alone or in combination with rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).
Based on all response assessments since the first dose of study drug until study discontinuation or the initiation of subsequent anticancer therapy, whichever was earlier, up to 65.1 months (the maximum participant's time on this study).
Part 3: Incidence of Treatment-emergent Adverse Events.
Time Frame: From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).
Treatment-emergent adverse events were used to characterize the safety of acalabrutinib in combination with rituximab and lenalidomide in participants with relapsed/refractory follicular lymphoma (R/R FL).
From the first dose of study drug until study discontinuation, 30 days after the last dose of study drug or one day before the first subsequent anticancer therapy, whichever was earlier, up to 54.3 months (the maximum participant's time on this study).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acerta Pharma BV

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2014

Primary Completion (Actual)

August 25, 2023

Study Completion (Estimated)

December 29, 2028

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimated)

July 3, 2014

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

September 30, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACE-LY-003
  • 2023-509350-63-00 (Registry Identifier: CTIS (EU))
  • 2019-000111-84 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Hodgkin Lymphoma

Clinical Trials on Lenalidomide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe