Non-Ablative Chemotherapeutic Conditioning Before Allogeneic Stem Cell Transplantation
- Determine the hematopoietic recovery in patients with hematologic malignancies or
genetic disorders treated with fludarabine and melphalan followed by allogeneic or
syngeneic bone marrow or peripheral blood stem cell transplantation.
- Determine the chemotherapeutic toxicity of this regimen in these patients.
- Determine the relapse and survival of patients treated with this regimen.
- Determine the incidence of graft-versus-host disease in patients treated with this
OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and
-2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin
on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood
stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis
comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone
beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on
day -3 and continuing until at least 6 months post-transplantation.
Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.
Primary Purpose: Treatment
David G. Savage, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Herbert Irving Comprehensive Cancer Center at Columbia University||New York, New York 10032|