Acalabrutinib + Combination Therapy for B-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is Acalabrutinib safe for humans?
Acalabrutinib has been shown to have a generally acceptable safety profile in humans, with common side effects including headache, diarrhea, and infections. Some studies noted an increased risk of neutropenia (low white blood cell count) and leukopenia (reduced white blood cells), but overall, it was considered to have a favorable safety profile compared to other treatments.12345
How is the drug Acalabrutinib unique for treating B-cell lymphoma?
Acalabrutinib is a highly selective Bruton tyrosine kinase inhibitor, which means it specifically targets a protein that helps cancer cells grow, making it potentially more effective and safer than other treatments. It has shown improved safety outcomes compared to similar drugs, with fewer off-target effects, and is used in combination with Rituximab to enhance its effectiveness in treating B-cell lymphoma.12346
What data supports the effectiveness of the drug combination Acalabrutinib, Lenalidomide, and Rituximab for B-Cell Lymphoma?
Rituximab, when used with chemotherapy, has shown significant effectiveness in treating various types of B-cell lymphomas, including non-Hodgkin lymphoma and chronic lymphocytic leukemia, by improving tumor remission and patient survival. This suggests that Rituximab, as part of a combination therapy, could be effective in treating B-cell lymphoma.7891011
Who Is on the Research Team?
Acerta Call center
Principal Investigator
Acerta Pharma, LLC
Are You a Good Fit for This Trial?
Adults over 18 with certain types of B-cell Non-Hodgkin Lymphoma that have relapsed or didn't respond to previous treatments. Participants must not be pregnant, should agree to use contraception if they can have children, and cannot have serious heart issues or gastrointestinal conditions that could affect the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive acalabrutinib alone or in combination with rituximab and lenalidomide for relapsed, refractory B-cell Non-Hodgkin Lymphoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Acalabrutinib
- Lenalidomide
- Rituximab
Acalabrutinib is already approved in United States, European Union for the following indications:
- Mantle cell lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Chronic lymphocytic leukemia
- Small lymphocytic lymphoma
- Mantle cell lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acerta Pharma BV
Lead Sponsor
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology