drugset / Trial / NCT00590447

Risk Stratified Sequential Treatment for CD20-positive PTLD

NCT00590447 ↗

Phase 2 Completed 152 enrolled Charite University, Berlin, Germany
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase-II trial will investigate the efficacy, safety and the tolerability of a sequential therapy consisting of 4 courses of single agent rituximab followed by 4 courses of R-CHOP chemotherapy in patients with CD20+ posttransplant lymphoproliferative disorders (PTLD). However, responders to rituximab achieving a CR after the first 4 applications of rituximab will go on with rituximab monotherapy and will not receive chemotherapy.

Timeline

Start
2006-12
Primary completion
2014-12
Completion
2015-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamid Unknown 750 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Subject Prednisone Other / unclassified 50 mg/m2 Oral
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Vincristine Small molecule 1.4 mg/m2 Intravenous