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

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.

Conditions

• AML

Interventions

PROCEDURE

allo-HSCT

allo-HSCT from any type of donor

Sponsors & Collaborators

• Botkin Hospital

  collaborator OTHER

• St. Petersburg State Pavlov Medical University

  collaborator OTHER

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

  collaborator OTHER

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

  collaborator OTHER_GOV

• Regional Clinical Hospital of Yaroslavl

  collaborator UNKNOWN

• Nizhny Novgorod regional clinical hospital named after N.A.Semashko

  collaborator UNKNOWN

• Clinical hospital №1 of Sverdlovsk region

  collaborator UNKNOWN

• Irkutsk regional clinical hospital, winner of the "Mark of the Honor" award

  collaborator UNKNOWN

• The Federal State-Financed Scientific Institution Kirov Research Institute of Hematology and Blood T

  collaborator OTHER_GOV

• National Research Center for Hematology, Russia

  lead NETWORK

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

59 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-02-01

Primary Completion

2026-02-01

Completion

2026-02-01

Countries

• Russia

Study Locations