drugset / Trial / NCT00481832

Autologous Followed by Non-myeloablative Allogeneic Transplantation for Non-Hodgkin's Lymphoma

NCT00481832

Phase 2 Terminated 50 enrolled Stanford University
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this trial is to develop an alternative treatment for patients with poor risk non-Hodgkin's lymphoma. This trial uses a combination of high dose chemotherapy with stem cell transplant using the patient's own cells. This is followed with non-myeloablative transplant using stem cells from a related or unrelated donor to try and generate an anti-lymphoma response from the new immune system.

Timeline

Start
2007-01
Primary completion
2014-10-27
Completion
2017-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject CD34+ Cells Cell therapy 2e+06 cells/kg
Subject Cyclophosphamide Other / unclassified 4 g Intravenous
Subject Etoposide Small molecule 60 mg/kg Intravenous
Subject Etoposide Small molecule 2 g Intravenous
Subject carmustine Small molecule
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 1.5 mg/kg Intravenous
Background Cyclosporine Peptide 5 mg/kg Oral
Background Methylprednisolone Other / unclassified 1 mg/kg
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications