A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Ma… (NCT04115631) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Comparison of Three Chemotherapy Regimens for the Treatment of Patients With Newly Diagnosed Mantle Cell Lymphoma
United States360 participantsStarted 2019-12-13
Plain-language summary
This phase II trial compares three chemotherapy regimens consisting of bendamustine, rituximab, high dose cytarabine, and acalabrutinib and studies how well they work in treating patients with newly diagnosed mantle cell lymphoma. Drugs used in chemotherapy, such as bendamustine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This study is being done to find out if one the drug combinations of bendamustine, rituximab, high dose cytarabine, and acalabrutinib is better or worse than the usual approach for mantle cell lymphoma.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Baseline measurements and evaluations must be obtained within 6 weeks of randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma.
* MIPI score must be calculated and entered in Oncology Patient Enrollment Network (OPEN).
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
* Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH). The diagnosis must be confirmed by formal hematopathology review at the enrolling center.
* Patients being treated with gastric reducing agents proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib.
* Absolute neutrophil count (ANC) \>= 1,000/mcL (obtained with 14 days of randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement:
* ANC \>= 500/mcL
* Platelets \>= 75,000 mcL (obtained with 14 days of randomization). If disease includes involvement or hypersplenism, please reference the below revised platelet requirement:
* Platelets \>= 25,000/mcL
* Total bilirubin =\< 2 x institutional upper limit of normal (ULN) (obtained with 14 d…