NCT02180711

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Acerta Pharma BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	acalabrutinib
DRUG	rituximab (IV)
DRUG	Lenalidomide

Timeline

• Start date: 2014-12-29
• Primary completion: 2023-08-25
• Completion: 2028-12-29
• First posted: 2014-07-03
• Last updated: 2025-10-15
• Results posted: 2025-10-15

Locations

32 sites across 3 countries: United States, Canada, Italy