Trial Information

Nonmyeloablative Allogeneic Stem Cell Transplantation in Elderly Patients With Hematological Malignancies:Results From the GITMO (Gruppo Italiano Trapianto Midollo Osseo)Multicenter Prospective Clinical Trial

A total of 35 patients with hematological malignancies were treated with fludarabine (30
mg/m2 x 3-5 days) and 200 cCy TBI followed by allogeneic hematopoietic stem cell
transplantation (HSCT) from a matched-sibling donor.

Neutrophil recovery occurred in 89% of the patients at a median time of 15 days. On day
+30, 10 patients had > 95% donor chimerism, and 21 patients had mixed chimerism. The
cumulative probabilities of grade II-IV acute GVHD and chronic GVHD were 51% and 84%
respectively. Transplant-related mortality at 100 days and 1 year was 5% and 9%
respectively. The probabilities of 1-year overall (OS) and progression-free survival (PFS)
were 55% and 47% respectively. The estimated 1-year probability of OS and PFS for patients
in early disease stages were 87% and 74% respectively , which were significantly higher than
the survival and PFS estimates of 12% obtained in patients with advanced disease stages at
the time of transplant