Background: AML has a particularly dismal prognosis in the elderly population. The OSHO, HOVON, SAKK and the French AML study groups performed a randomized phase III study comparing Hematopoietic Stem Cell Transplantation (HSCT) to conventional chemotherapy in these patients. Methods: Patients aged 60 – 75 years with AML CR1 (except FAB M3) were registered after induction(s) according to study group protocols. A donor search was initiated during consolidation. Patients with a related or matched unrelated donor were randomized within 150 days of diagnosis to receive either HSCT or non-HSCT in a 2:1 ratio. Patients in the HSCT arm were treated with Fludarabine/200 cGy total body irradiation followed by cyclosporine/mycophenolate mofetil. Patients in the non-HSCT arm continued therapy according to the study group protocols. Leukemia free survival was chosen as primary endpoint. Patients without a donor were included in the observation arm. Results: A total of 245 patients from 23 centers in five countries were registered and started consolidation. Sixty six patients (26.9%) exited the study before randomization because of relapse/no recovery (28), toxicities (10), consent withdrawal (10), patient choice (7), death (6) or miscellaneous reasons (5). Donors were identified for 135 (75.9%) of the 179 patients, 22.9% related and 77.0% unrelated. Ten patients with donors were allocated to the observation arm because of consent withdrawal, ineligibility, protocol violation or unknown reasons. Randomization proceeded for 125 (51,0%) patients. Of the 83 in the HSCT arm, 16 were not transplanted. Of the 42 patients in the non-HSCT arm, 6 did not receive the scheduled second consolidation and information is pending in 7. Endpoint analysis is due in 2020. Conclusions: The feasibility of HSCT for elderly patients with AML CR1 within 150 days from consolidation was demonstrated in a randomized European study. Donor identification and randomization was achieved for a large proportion of patients (75,9% and 51,0%). Despite a short treatment interval of ≤12 weeks from consolidation to HSCT/non-HSCT, relapse (n = 39) and toxicities (n = 14) were the most frequent cause of end of study. Clinical trial information: EudraCT Number 2007-003514-34.