A Phase II Study of Reduced Intensity Allogeneic Bone Marrow Transplant for the Treatment of Myelodysplastic Syndromes
- Determine the complete response rate in patients with myelodysplastic syndromes treated
with reduced-intensity allogeneic bone marrow transplantation, including photopheresis,
total body irradiation, and pentostatin.
- Determine the disease-free and overall survival of patients treated with this regimen.
- Determine the engraftment rate of donor cells in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the extent and duration of acute and chronic graft-versus-host disease in
patients treated with this regimen.
OUTLINE: This is a multicenter study.
- Preparative Regimen: Patients undergo photopheresis using methoxsalen on days -7 and -6
and receive pentostatin IV continuously on days -5 and -4. Total body irradiation is
administered on days -3 and -2 for a total of 3 doses.
- Transplantation: Allogeneic bone marrow or peripheral blood stem cells are infused on
- Acute graft-vs-host-disease (GVHD) prophylaxis: Patients receive cyclosporine IV on
days -1 to 30 and then orally every 12 hours. Cyclosporine dose is then tapered
beginning after day 50 and continuing for 6 months in the absence of GVHD. Once
cyclosporine dose is significantly decreased, oral mycophenolate mofetil (MMF) is then
administered twice a day. MMF dose is then tapered for 12 months in the absence of
GVHD. Patients also receive methotrexate IV on days 1 and 3.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study within 2.1 years.
Masking: Open Label, Primary Purpose: Treatment
Complete response rate at day 100 after transplant
Selina M. Luger, MD
Abramson Cancer Center of the University of Pennsylvania
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|Tufts-NEMC Cancer Center||Boston, Massachusetts 02111|
|Jewish Hospital Cancer Center||Cincinnati, Ohio 45236|
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|