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

Non Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02180711
• Other study ID #: ACE-LY-003
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: December 29, 2014
• Est. completion date: December 29, 2028

Study information

• Verified date: April 2024
• Source: Acerta Pharma BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: December 29, 2028
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Non Hodgkin Lymphoma

Intervention

Drug:
• acalabrutinib

• rituximab (IV)

• Lenalidomide

Locations

Country	Name	City	State
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	London	Ontario
Canada	Research Site	Toronto	Ontario
Italy	Research Site	Bologna
Italy	Research Site	Milano
Italy	Research Site	Palermo
United States	Research Site	Ann Arbor	Michigan
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Chicago	Illinois
United States	Research Site	Columbus	Ohio
United States	Research Site	Coral Gables FL	Florida
United States	Research Site	Dallas	Texas
United States	Research Site	Downey	California
United States	Research Site	Duarte	California
United States	Research Site	Fountain Valley	California
United States	Research Site	Greenville	South Carolina
United States	Research Site	Hawthorne	New York
United States	Research Site	Houston	Texas
United States	Research Site	Lake Success	New York
United States	Research Site	Louisville	Kentucky
United States	Research Site	Morristown	New Jersey
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Salt Lake City	Utah
United States	Research Site	San Antonio	Texas
United States	Research Site	Santa Monica	California
United States	Research Site	Spokane	Washington
United States	Research Site	Syracuse	New York
United States	Research Site	Temple	Texas
United States	Research Site	Tucson	Arizona
United States	Research Site	Waukesha	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Acerta Pharma BV	AstraZeneca

Countries where clinical trial is conducted

United States,  Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment Emergent Adverse Events (AEs)	Number of participants who had experienced at least one treatment emergent AE	From first dose of study drug to within 30 days of last dose of study drug