EA4181 A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients equal to 70 years old with Untreated Mantle Cell Lymphoma
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
The purpose of this study is to compare the usual treatment of 1) bendamustine, rituximab, and high dose cytarabine to using 2) bendamustine, rituximab, high dose cytarabine, and acalabrutinib and 3) bendamustine, rituximab, and acalabrutinib to find out if these different approaches are better, the same, or worse than the usual approach. To decide if they are better, the study doctors will be looking to see which treatment combinations shrink patients’ cancer the most.
Generally healthy adults with mantle cell lymphoma (MCL) that has never been treated may be eligible.
If you decide to take part in this study, you will receive one of the following drug combinations for six cycles with a cycle length of 28 days for a total of 6 months of treatment or until your disease gets worse or the side effects become too severe:•Bendamustine, rituximab and high dose cytarabine;•Bendamustine, rituximab, high dose cytarabine and acalabrutinib;•Bendamustine, rituximab and acalabrutinibAfter you finish your study treatment, your doctor will continue to follow your condition for 10 years and watch you for side effects. You will see your doctor every 3 months for 3 years, and then every 6 months until the end of the 10 year period. You should discuss with your doctor how to treat your MCL after you complete this protocol.
08/08/2020 05:02 AM