Prospective Multicenter Randomized Controlled Clinical Trial for Evaluation the Role of Allo-HSCT in the First Complete Remission, MRD-negative After the First Course, in Patients With AML Under the Age of 60 Years
Depending on the variant of the disease, patients are divided into 3 groups: A, B and C. Group A include patients with acute myeloid leukemia (AML) inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11, group B - AML with t(8;21)(q22;q22.1); RUNX1-RUNX1T1, AML with normal karyotype with or without gene mutations (FLT3, NPM1, CEBPa) regardless of the allele ratio, and also AML with cytogenetic abnormalities not classified as those within groups A/C, group C - AML with myelodysplasia-related changes. Patients from group A receive treatment according to the scheme: 2 courses 7+3, 2 courses FLAG, then - 6 courses of maintenance therapy according to the scheme 5+5. Patients from group B are given one course of 7+3. After that, their minimal residual disease (MRD) status is assessed. In case MRD negativity is achieved after the 1st course of 7 +3, randomization is carried out: branch 1 - therapy is similar to therapy for patients from group A (4 courses of induction and consolidation + 6 courses of maintenance chemotherapy (CT), allogeneic hematopoietic stem cell transplantation (allo-HSCT) is not planned), branch 2 - performing allo-HSCT should be done as soon as possible (before the start of maintenance CT is most desirable). If MRD negativity is not achieved after the 1st course of 7+3, the patient is given CT according to the standard program, followed by mandatory allo-HSCT. Patients from group C are treated either according to the Aza-Ida-Ara-C scheme, or according to the Ven-DAC /AZA scheme, followed by mandatory allo-HSCT.
• Newly diagnosed, previously untreated AML;
• Age from 18 to 59 years;
• Somatic status - ECOG \< 3.