drugset / Trial / NCT00043810

Study of Gelonin Purging of Autologous Stem Cells for Transplantation

NCT00043810

Phase 1/2 Terminated 3 enrolled M.D. Anderson Cancer Center
RandomizedSingle-groupOpen-labelTreatment

Summary

Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and autologous bone marrow transplantation has been shown to be effective in this group of patients but hematopoietic recovery is slow, and infectious or bleeding complications are common. The delay in hematopoietic recover is accentuated by the use of purging techniques. This is a novel purging approach for autologous stem cell transplantation in patients with Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a lower relapse rate therefore improving the therapeutic outcomes

Timeline

Start
2002-07
Primary completion
2005-03
Completion
2005-03

Drugs

EvaluationDrugModalityDoseRoute
Background Busulfan Small molecule 130 mg/m2 Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous