Phase 2 Trial Comparing RituximabBendamustine Alone or Alternating With RituximabBendamustineCytarabine in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for Stem Cell Transplant

What this Trial Is About

Researchers are evaluating the safety and effectiveness of two different chemotherapy combinations as first-line treatment for elderly patients with mantle cell lymphoma who cannot undergo high-dose therapy followed by stem cell transplantation. This phase 2, multicenter, open-label randomized trial compares rituximab and bendamustine RB alone with a regimen alternating between rituximabbendamustine RB and rituximabbendamustinecytarabine RBAC. Participants are randomly assigned to one of two groups. One group receives six cycles every four weeks, alternating between RB on odd cycles 1st, 3rd, 5th and RBAC on even cycles 2nd, 4th, 6th. The RB treatment includes rituximab and bendamustine, while RBAC adds cytarabine to the combination. The other group receives six cycles of RB alone every four weeks. Patients are stratified by age, lymphoma cell type, and risk score. During the study, participants will undergo regular assessments to monitor their response and any side effects. The main measure is progression-free survival over up to 84 months, along with overall survival, duration of response, event-free survival, response rates, and adverse events. Researchers will evaluate these outcomes to understand how well each treatment regimen works and its safety profile for this patient group.

A Study Comparing Rituximab/Bendamustin(RB) Alternating With Rituximab/Bendamustin/Cytarabin(RBAC) With RB Therapy in Elderly Patients With Mentle Cell Lymphoma