PB1866: IS ALLO-HSCT IN CR1 NECESSARY FOR AML PATIENTS WITH MRD NEGATIVITY ACHIEVED AFTER THE FIRST INDUCTION COURSE? RUSSIAN PROSPECTIVE MULTICENTER RANDOMIZED TRIAL IN AML PATIENTS UNDER THE AGE OF 60

• DOI: 10.1097/01.hs9.0000974300.64022.c0
• Publication Date: 2023-08-09T14:00:26Z
• Authors: Elena Parovichnikova; Irina Lukianova; Irina Galtzeva; Anastasiya Kashla...; Zalina Fidarova; Olga Aleshina; Larisa Kuzmina; Vera Troitskaya; Mikhail Drokov; Andrey Sokolov; Sergej Bondarenko; Olga Samoilova; Mariya Grishunina; Tatiana Konstanti...; Yuliya Sveshnikova; Natalia Minaeva; Elena Zinina; Valerij Lapin; Kamil Kaplanov; Sergej Gritsaev; Elena Gribanova; Valentina Dvirnyk; Tatiana Obukhova; Andrej Sudarikov; Yuliya Chabaeva
• Keywords: Publication Only; Diseases of the blood and blood-forming organs; RC633-647.5

Topic: 4. Acute myeloid leukemia - Clinical Background: AML is heterogeneous disease with much fewer treatment options. 7 + 3 and different high dose ARA-C combinations are still the mainstream approaches for patients that fit intensive therapy. New AZA+ven has emerged elderly or unfit pts, but there few publications about its efficacy as first line in youngs pts de novo AML, especially myelodysplasia related changes (MRC-AML). The question whether allo-HSCT necessary CR1 if MRD-negativity was achieved after 1st induction course sustains afterwards remains open Aims: To define a randomized fashion role of who MRD-negative CR cycle disregard ELN risk group (excluding MRC-AML inv16) Methods: In Feb 2021 Russian Leukemia study initiated multicenter prospective clinical trial registered on ClinTrialGov NCT05339204. 2017 WHO 2016 classification were used patients’ stratification. Induction consolidation planned to be (low intensive: Aza-Ven Aza-LDIda-LDAra-C) all other types (two (dauno 60m2) two FLAG cycles, followed by 6 maintenance 5 cycles 6MP). Cytogenetic molecular testings done MRD also monitored MFC centralized lab. Pts markers parallel PCR. (group C) candidates early (within 4 cycles). Inv16 A) considered only persisted 4th at levels increasing. All included Group B, those cycles) no (or postponed case MRD-conversion) Results: 104 from 11 Centers enrolled Nov 2022. 9 (inv16 AML) have formed A (8,6%), 73 – B (70,3%), 22 C (21,1%). 84 eligible evaluation min 2 inductions. Total rate 76,2% (Group 100%, 75,4%, 66,7%), 60-day mortality 10,7% (A-0%, 15,8%, 11,1%), refractory 8,8%, 22,2%). among 48 43 ind. 33 them (76,7%) MRD-negative. So 29 randomized: 14 (7 performed median time 6,3 mо), 15 allo-HSCT. 10 MRD-positive directed allo-HSCT, transplanted Me 5,5 mo. allocated (70% already allo-HSCT=2,9 mo). No one A, late relapse 2nd CR. 1-year OS whole cohort 70%, DFS 73%. It’s too compare groups. 1-y Gr. =100%, 74%, 50%. 68%, 75% Summary/Conclusion: our knowledge investigating groups.The results demonstrated it took long achievement majority 5,5-6,3 reached somewhat earlier 2,9 mo, DFS. Further follow-up will answer posed questionKeywords: HSCT, leukemia, Minimal residual (MRD)