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

NCT ID: NCT02180711

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-29
• Study Completion Date: 2028-12-29

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

Conditions

Non Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: acalabrutinib Regimen 1

acalabrutinib Regimen 1 for relapsed, refractory Follicular Lymphoma subjects

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

Part 1: acalabrutinib Regimen 2

acalabrutinib Regimen 2 + rituximab for relapsed, refractory, or treatment naive Follicular Lymphoma subjects

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

rituximab (IV)

Intervention Type: DRUG

Part 2: acalabrutinib Regimen 1

acalabrutinib Regimen 1 for relapsed, refractory Marginal Zone Lymphoma subjects

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

Part 2: acalabrutinib Regimen 2

acalabrutinib Regimen 2 + rituximab for relapsed, refractory Marginal Zone Lymphoma subjects

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

rituximab (IV)

Intervention Type: DRUG

Part 3: acalabrutinib Regimen 1

acalabrutinib Regimen + lenalidomide + rituximab for relapsed, refractory Follicular Lymphoma subjects

Group Type: EXPERIMENTAL

acalabrutinib

Intervention Type: DRUG

rituximab (IV)

Intervention Type: DRUG

Lenalidomide

Intervention Type: DRUG

Interventions

acalabrutinib

Intervention Type: DRUG

rituximab (IV)

Intervention Type: DRUG

Lenalidomide

Intervention Type: DRUG

Other Intervention Names

ACP-196

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: 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Acerta Pharma BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Tucson, Arizona, United States

Research Site

Downey, California, United States

Research Site

Duarte, California, United States

Research Site

Fountain Valley, California, United States

Research Site

Santa Monica, California, United States

Research Site

Coral Gables FL, Florida, United States

Research Site

Chicago, Illinois, United States

Research Site

Chicago, Illinois, United States

Research Site

Chicago, Illinois, United States

Research Site

Louisville, Kentucky, United States

Research Site

New Orleans, Louisiana, United States

Research Site

Ann Arbor, Michigan, United States

Research Site

Morristown, New Jersey, United States

Research Site

Hawthorne, New York, United States

Research Site

Lake Success, New York, United States

Research Site

New York, New York, United States

Research Site

Syracuse, New York, United States

Research Site

Columbus, Ohio, United States

Research Site

Greenville, South Carolina, United States

Research Site

Dallas, Texas, United States

Research Site

Houston, Texas, United States

Research Site

San Antonio, Texas, United States

Research Site

Temple, Texas, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Spokane, Washington, United States

Research Site

Waukesha, Wisconsin, United States

Research Site

Edmonton, Alberta, Canada

Research Site

London, Ontario, Canada

Research Site

Toronto, Ontario, Canada

Research Site

Bologna, , Italy

Research Site

Milan, , Italy

Research Site

Palermo, , Italy

Countries

United States; Canada; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=ACE-LY-003&attachmentIdentifier=9c32d093-ff79-4c9c-8964-d247ffdc898d&fileName=ace-ly-003-csp-v8_CCI_redacted_Redacted_pdfa.pdf&versionIdentifier=

Redacted CSP

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Redacted SAP

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Redacted CSR synopsis

Other Identifiers

2023-509350-63-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2019-000111-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACE-LY-003

Identifier Type: -

Identifier Source: org_study_id