drugset
drugset / Trial / NCT00822770

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin

NCT00822770 ↗

Phase 1/2 Completed 47 enrolled M.D. Anderson Cancer Center Genzyme, a Sanofi Company · collab
RandomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn about the safety of AMD3100 (plerixafor) and G-CSF (filgrastim) in combination with fludarabine, busulfan, and an allogeneic blood stem cell transplant. This treatment will be studied in patients with acute myeloblastic leukemia (AML), myelodysplastic syndromes (MDS), or Chronic myelogenous leukemia (CML).

Timeline

Start
2009-01
Primary completion
2012-10
Completion
2012-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Plerixafor Small molecule 0 ug/kg Subcutaneous
Subject Plerixafor Small molecule 80 ug/kg Subcutaneous
Subject Plerixafor Small molecule 160 ug/kg Subcutaneous
Subject Plerixafor Small molecule 240 ug/kg Subcutaneous
Subject filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous
Background Busulfan Small molecule 130 mg/m2 Intravenous
Background Fludarabine Small molecule 40 mg/m2 Intravenous
Background Thymoglobulin Unknown 2 mg/kg Intravenous

Indications

disease related to hematopoietic stem cell transplant leukemia