Objective: To investigate the therapeutic effect of conditioning regimen containing fludarabine in nonmyeloablative allogeneic peripheral blood stem cells transplantation (NAST) in the treatment of hematological diseases.
Methods: Thirty-six patients with acute leukaemia, severe aplastic anaemia, MDS and myelofibrosis received NAST from HLA matched donors' G-CSF mobilized peripheral blood stem cells after nonmyeloabalative conditioning. The conditioning regimen consisted of CTX, Ara-C, CsA, anti-CD(3) antibody or anti-thymocyte globulin and with or without fludarabine. GVHD prophylaxis was performed with cyclosporine combined methotrexate (no MMF group, n = 5) or mycophenolate mofetil (MMF group, n = 31).
Results: All of the treatment was generally well tolerated and all cases achieved engrafted of the donor cells. In fludarabine group, engraftment was observed in 87.5% (14/16) patients with complete donor chimerism, graft failure was 12.5% (2/16) and in no fludarabine group, 80% (16/20) and 20% (4/20), respectively. The incidence of acute GVHD (grade I - IV) was 27.8% (10/36) and chronic GVHD 22.2% (8/36). In fludarabine group, grade I - II aGVHD was 37.5%, in no fludarabine group, 20%. cGVHD was 12.5% in fludarabine group and in no fludarabine group 30%, respectively. Interstitial pneumonia (IP) was observed in 16.7% (6/36) of the patients, being 18.7% (3/16) and 15% (3/20) in fludarabine and no fludarabine group, respectively. Overall survival rate was 80.5% (29/36) with a median follow-up of 13 months.
Conclusions: There was no significant difference between fludarabine based (n = 16) and non-fludarabine based conditioning regimen (n = 20) in NAST for the treatment of hematological diseases, regarding for incidence of GVHD, IP, engraftment and survival.