CONSOLIDATION TREATMENT OF ADULT ACUTE LYMPHOBLASTIC-LEUKEMIA - A PROSPECTIVE, RANDOMIZED TRIAL COMPARING ALLOGENEIC VERSUS AUTOLOGOUS BONE-MARROW TRANSPLANTATION AND TESTING THE IMPACT OF RECOMBINANT INTERLEUKIN-2 AFTER AUTOLOGOUS BONE-MARROW TRANSPLANTATION

A prospective, randomized trial was initiated in adult acute lymphobla stic leukemia (ALL) to compare (1) disease-free survival (DFS) after a llogeneic or autologous bone marrow transplantation (BMT) and (2) the relapse rate of patients treated with or without interleukin-2 (IL-2) after autologous BMT. A total of 135 previously untreated patients, ag ed under 55 years, received the Berlin-Frankfurt-Muster (BFM) inductio n regimen: 126 patients (93%), of which 120 were HLA-typed, achieved c omplete remission (CR). According to this genetic randomization, patie nts with (n = 43) or without an HLA-identical sibling (n = 77) were to receive allogeneic or autologous BMT, respectively. The 3-year post-C R probability of DFS was significantly higher in the HLA-identical sib ling group than in the non-HLA-identical sibling group (68% v 26%; P < .001). Eligible patients were randomized to receive (n = 30) or not to receive (n = 30) IL-2 after autologous BMT: the 3-year post-BMT proba bility of continuous CR was similar in both groups (29% v 27%, respect ively). We conclude that, in ALL, early allogeneic BMT after the BFM i nduction regimen is an effective consolidation treatment and that IL-2 does not decrease the high relapse rate observed after autologous BMT . (C) 1995 by The American Society of Hematology.