The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission - Trial NCT05339204

Timeline & Enrollment

Primary Outcome

Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo,Relapse probability

Summary

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.

ICD-10 Classifications