drugset / Trial / NCT00053014

S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

NCT00053014

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE: Phase II trial to study the effectiveness of chemotherapy and total-body irradiation followed by donor peripheral stem cell transplantation, cyclosporine, and mycophenolate mofetil in treating older patients who have acute myeloid leukemia.

Timeline

Start
2003-04
Primary completion
2005-06
Completion
2006-06

Drugs

EvaluationDrugModalityDoseRoute
Subject therapeutic allogeneic lymphocytes Cell therapy Intravenous
Background Cyclosporine Peptide 6.25 mg/kg Oral
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule 15 mg/kg Oral

Indications