AUTOLOGOUS TRANSPLANTATION WITH PERIPHERAL-BLOOD STEM-CELLS COLLECTEDAFTER GRANULOCYTE-COLONY-STIMULATING FACTOR IN PATIENTS WITH ACUTE MYELOGENOUS LEUKEMIA

The use of peripheral blood stem cells (PBSC) with or without bone mar row (BM) in patients with acute myelogenous leukemia (AML) undergoing autologous transplantation in untreated first relapse (Rel1) or in sec ond remission (CR2) was evaluated in a phase II study, Twenty-three pa tients with AML in untreated Rel1 (n = 8) and CR2 (n = 15) underwent a utologous transplant using PBSC with (n = 19) or without (n = 4) BM, S ix patients received busulfan (BU) and cyclophosphamide (CY) and 17 re ceived BU, CY and total body irradiation prior to transplant, The medi an number of CD34(+) cells infused was 4.81 x 10(6)/kg (range 0.04-15) , Fifteen of 23 patients received post-transplant interleukin-2 (IL-2) at a median of 43 days (range 11-93) in an attempt to decrease relaps es, The median day of recovery of granulocytes to 0.5 x 10(9)/l was 12 (range 8-27) and platelets to 20 x 10(9)/l was 15 (range 8-103), Pati ents received a median of 4 units (range 0-20) of red blood cells and 29 units (range 4-252) of platelets, The probability of 100 day non-re lapse mortality was 0.14, The probabilities of survival and relapse at 2 years were 0.24 and 0.65, respectively, The probabilities of relaps e in patients receiving (n = 15) and not receiving (12 = 8) interleuki n-2 (IL-2) were 0.59 and 0.74, respectively (P = 0.1), Overall, seven of 23 (30%) patients are alive and continuously disease-free at a medi an of 483 days (range 113-835) post-transplant. These data demonstrate that the infusion of PBSC collected after rhG-CSF corrected engraftme nt problems previously observed with autologous BM transplants in pati ents with AML but was associated with a high relapse rate.