drugset / Trial / NCT01661881

Rituximab/Bendamustine + Rituximab/Cytarabine for Mantle Cell Lymphoma

NCT01661881 ↗

Phase 2 Active not recruiting 23 enrolled Christine Ryan Beth Israel Deaconess Medical Center · collab
NaSingle-groupOpen-labelTreatment

Summary

Mantle cell lymphoma (MCL) is not curable with conventional therapy. This study sought to improve upon standard of care in newly diagnosed, untreated MCL patients who were transplant-eligible using drugs already established as active in MCL. The combination of Rituximab-Bendamustine followed by Rituximab-Cytarabine (RB/RC) was expected to maximize pre-ASCT complete response (CR) rate compared to historical rates approximating 55% with tolerable toxicity.

Timeline

Start
2012-08-16
Primary completion
2015-02
Completion
2030-04

Outcome

Met primary endpoint

paper 96% of patients achieved a CR/unconfirmed CR after treatment, meeting the primary objective. PMID 26729345 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2 —
Subject Cytarabine Small molecule 1 g —
Subject Cytarabine Small molecule 1.5 g —
Subject Cytarabine Small molecule 2 g —
Subject Cytarabine Small molecule 3 g —
Subject Rituximab Monoclonal antibody 375 mg/m2 —

Indications