drugset / Trial / NCT01458548

Sequential Treatment of CD20-positive Posttransplant Lymphoproliferative Disorder (PTLD)

NCT01458548 ↗

Phase 2 Terminated 70 enrolled Charite University, Berlin, Germany
NaSingle-groupOpen-labelTreatment

Summary

Post-transplantation lymphoproliferative disorder (PTLD) develops in one to ten per cent of transplant recipients and can be EBV-associated. To improve long-term efficacy after rituximab monotherapy and to avoid the toxicity of CHOP seen in first-line treatment, the investigators initiated an international multicentre phase II trial to test whether the subsequent application of rituximab and four courses of three-weekly CHOP would improve the outcome of patients with PTLD: PTLD-1, sequential treatment (ST).

Timeline

Start
2002-12
Primary completion
2008-05
Completion
2011-10

Outcome

Outcome not reported

Stopped: “This study had an major amendment in 12/2006 introducing risk stratified sequential treatment (RSST). The modified protocol is registered with NCT00590447.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 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