drugset / Trial / NCT00571662

Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant

NCT00571662

NaSingle-groupOpen-labelTreatment

Summary

This is a continuation of a pilot study which is now regarded as a phase II trial with a plan to enroll an additional 40 patients (20 related and 20 unrelated donor transplants) with hematological malignancy assessing the safety and efficacy of a minimally myelosuppressive regimen with pentostatin and low-dose total body irradiation (TBI) followed by allogeneic peripheral blood stem cell transplantation (alloPSCT).

Timeline

Start
2000-12-08
Primary completion
2008-12-30
Completion
2008-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Pentostatin Small molecule 4 mg/m2 Intravenous
Background Cyclosporine Peptide 2 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral
Background sargramostim Protein / enzyme biologic 10 ug/kg Subcutaneous