drugset / Trial / NCT01786018

Thiotepa, Busulfan and Fludarabin for pt With Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas

NCT01786018

Phase 2 Unknown 42 enrolled Azienda Ospedaliera San Giovanni Battista
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.

Timeline

Start
2013-02
Primary completion
2015-02
Completion
2015-02

Drugs

EvaluationDrugModalityDoseRoute
Background ATG Unknown 2.5 mg/kg
Background Busulfan Small molecule 3.2 mg/kg Intravenous
Background Cyclosporine Peptide 5 mg/kg Oral
Background Fludarabin Unknown 50 mg/m2
Background Methotrexate Small molecule 10 mg/m2 Intravenous
Background Thiotepa Other / unclassified 5 mg/kg