Abstract
7080 Background: In order to compare current treatment strategies, four multicenter trial groups in Germany joined for a prospective, individual patient data based study. Methods: To guarantee comparability all patients before treatment started were randomized by phone call to the shared statistical center, to receive either the trial own treatment (90% patients) or a common standard treatment (10%). The common standard arm uniformly contained two courses of CALGB derived araC 100 mg/m²/dx7 and daunorubicin 60 mg/m2/d×3 and in patients attaining complete remission (CR) 3 courses of high-dose araC (HIDAC) 3 g/m2q12h×6. By their trial own treatment the participating trials addressed own strategies. Thus, HIDAC in induction (trial 1) and early allogeneic stem cell transplantation (SCT) (trial 2) were administered in patients with high-risk features and/or slow response. Randomized comparisons of one versus two induction courses by HIDAC/mitoxantrone, and prolonged maintenance versus autologous SCT were done in trial 3, and HIDAC 1g/m2 q12h × 8 versus 2g/m2/d × 4 in trial 4. These trial own randomizations did not result in significant differences of outcome. Results: The four trial populations and the standard arm will be compared according to intention-to-treat with the event-free survival as primary clinical endpoint. Differences will be tested using a log rank test as well as the probability of EFS at 3 years with 95% CI. The upcoming analyses will be after the end of patient's accrual. The current duration of follow-up is 15 (1–53) months. No significant financial relationships to disclose.
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