drugset / Trial / NCT00231309

Granulocyte Colony Stimulating Factor (G-CSF) for Bone Marrow Transplant (BMT)

NCT00231309

Completed 10 enrolled Emory University
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The major purpose of this study is to evaluate the curative potential of white cell growth hormone (G-CSF)-stimulated bone marrow cells in allogeneic bone marrow transplants. Patients with cancers or blood diseases, who have poor potential for a cure with standard treatment, will be able to participate in the study. Donors will receive the white cell growth hormone (G-CSF) as a shot (injection) in their arm once a day for three days before they donate their bone marrow cells. Total body irradiation and/or chemotherapy will be given first to prepare the patient's body for the infusion of new bone marrow cells from the donor. Two medicines (cyclosporine and methotrexate) will be used to prevent the new bone marrow cells (graft) from attacking the patient's body (host) (graft-versus-host disease; GVHD). Certain safety checkpoints were built into the study if unwanted/unexpected events were to occur. If the outcomes appear better than could be expected, this will provide a bridge to extend this current approach for other innovative therapies.

Timeline

Start
2003-07
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Granulocyte colony-stimulating factor Protein / enzyme biologic 5 ug/kg Other