Mobilisation of healthy donors with lenograstim and transplantation of HLA-genoidentical blood progenitors in 54 patients with hematological malignancies: a pilot study

Blood cell transplantation (BCT) is now common practice in the autologous s etting. We performed a pilot study of allogeneic BCT, collected after the p riming of an HLA-identical sibling with a glycosylated rhu-G-CSF (lenograst im) (10 mu g/kg). Fifty-four patients were included (38 +/- 11; M/F = 33/21 ; CML (n = 17), AML (n = 14), ALL (n = 15); MDS (rt = 8)), Transplant proce dures were standard (TBI regimen = 47 (87 %); MTX-CsA: 11 =37; CsA-PDN: n=1 7), No serious adverse events were reported in donors. A median of 11 (3.5- 29.1)x 10(6)/kg CD34(+) cells, 332 (33-820)x 10(6)/kg CD3(+) cells were col lected. Four patients did not engraft (early death: n=2; graft failure: n=2 ), Fifty-one patients initially recovered 0.5 x 10(9)/l ANC and 25 x 10(9)/ l platelets at 15 (10-30) and 13 (9-188) days. 29/51 and 29/38 experienced grade greater than or equal to 2 acute and chronic GVHD, With a median foll ow-up of 25 months (18-36), relapse rate is 16%, +/- 8, survival and DFS pr obabilities are similar (50% -/+ 13), A better outcome is documented for pa tients under 45 years and in the early phase of the disease (n = 28), with an identical survival and DFS of 71% +/- 13, In conclusion, lenograstim is a potent rhu-G-CSF for mobilisation of allogeneic hematopoietic progenitors . Two-year follow-up indicates good haematological recovery but some concer ns about graft failure and chronic GVHD have arisen deserving prospective e valuation.