Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Roswell Park Cancer Institute
OBJECTIVES: * Determine the safety and toxic effects of nonmyeloablative allogeneic peripheral blood stem cell transplantation in patients with a hematologic malignancy or aplastic anemia. * Determine clinical response and overall outcome of patients treated with this regimen. * Determine the incidence of graft-vs-tumor effect, graft-vs-host disease, and chimerism in patients treated with this regimen. OUTLINE: * Preparative regimen: * Matched related and unrelated donor transplantation: * Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and fludarabine IV over 30 minutes on days -5 to -1. * Cord blood transplantation: * Patients receive the same regimen as above plus anti-thymocyte globulin IV over 4 hours on days -3 to -1. * Graft-vs-host disease (GVHD) prophylaxis: * Matched related and unrelated donor transplantation: * Patients receive oral tacrolimus (or IV) once daily and oral mycophenolate mofetil (MMF) (or IV) twice daily on days -1 to 60 followed by tapering\* of this regimen. Patients then receive methotrexate IV on days 1, 3, and 6. * Cord blood transplantation: * Patients receive tacrolimus and MMF in the same regimen as above plus methylprednisolone twice daily on days 1-19 or until blood counts recover. * Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive sargramostim (GM-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover. * Donor lymphocyte infusion (DLI): Patients not converting to 100% donor T-cell chimerism by day 120 and showing signs of progresson of disease after tacrolimus and MMF withdrawal may receive DLI every 8 weeks for up to 3 infusions. Cord blood recipients do not receive DLI. Patients are followed at day 100-120, every 3 months for 2 years, and then every 6 months for 5 years. PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 6-7 years.
Age
4–75
Sex
ALL
Healthy volunteers
Not accepted
