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 = 70 years old with Untreated Mantle Cell Lymphoma | NYU Langone Health

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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 = 70 years old with Untreated Mantle Cell Lymphoma

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

Conditions:
Lymphoma Mantle Cell
Age: Between 18 years - 70 years
Gender: Male or Female

Other Inclusion Criteria:

1) Patient must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or FISH as confirmed by the enrolling center. 2) Baseline measurements and evaluations must be obtained within 42 days prior to randomization to the study. 3) Patient must have at least one objective measurable disease parameter.

You may not be eligible for this study if the following are true:

1) He/she requires treatment with a strong cytochrome P450 (CYP) 3A inhibitor. 2) Malabsorption syndrome or disease significantly affecting gastrointestinal function. 3) Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease). 4) Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon) within 7 days prior to first dose of study drug.