Finding studies
Finding studies
Take this into the appointment.
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Lead
Fred Hutchinson Cancer Center
With
PRIMARY OBJECTIVES: I. To compare the effectiveness of 2 GVHD prophylaxis regimens in preventing acute grades II-IV GVHD. SECONDARY OBJECTIVES: I. Compare non-relapse mortality in the 2 arms. II. Compare survival and progression-free survivals in the 2 arms. OUTLINE: Patients are randomized to 1 of 2 treatment arms. All patients receive FLU intravenously (IV) over 30 minutes on days -4 to -2 followed by 2-3 Gy TBI on day 0. ARM 0: Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Arm removed as of 14-Sep-2011 ARM I: Patients receive CSP orally (PO) twice daily (BID) on days -3 to 96 with taper to day 150 and MMF PO three times daily (TID) on days 0-29 and then BID on days 30-150 with taper to day 180. ARM II: Patients receive CSP as in Arm I and sirolimus PO once daily (QD) on days -3 to 150 with taper to day 180. Patients also receive MMF PO TID on days 0-29 and then BID on days 30-40. MMF will then be discontinued without taper unless GVHD or disease relapse/progression occurs. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 following the TBI. After completion of study treatment, patients are followed up periodically.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
