drugset / Trial / NCT01592981

Randomised Trial in Waldenstrom's Macroglobulinaemia

NCT01592981 ↗

Phase 2 Completed 60 enrolled University College, London
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this trial is to assess tolerability and efficacy of the Bortezomib, Cyclophosphamide and Rituximab combination as initial therapy for previously untreated patients with symptomatic Waldenstrom's macroglobulinaemia.

Timeline

Start
2013-01
Primary completion
2017-03
Completion
2020-08-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Bortezomib Small molecule 1.6 mg/m2 Subcutaneous
Subject Cyclophosphamide Other / unclassified 250 mg/m2 Oral
Comparator Fludarabine Small molecule 40 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous