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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2026-02-01

Brief Summary

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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.

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Detailed Description

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"7+3" regimen:

1. Cytarabine 200 mg/m2 (IV continuous infusion over 24 hours), days 1-7
2. Daunorubicin 60 mg/m2 (IV bolus), days 1-3

"FLAG" regimen:

1. Fludarabine 25 mg/m2 (IV in 30 minutes), days 1-5
2. Cytarabine 1500 mg/m2 (IV in 3 hours), days 1-5
3. Granulocyte colony-stimulating factor 5 mcg/kg (subcutaneous injection), from day 6 until regression of cytopenia

"Aza-Ida-Ara-C" regimen:

1. Azacitidine 75 mg/m2 (subcutaneous injection), days 1-3
2. Idarubicin 3 mg/m2 (IV bolus), days 4-10
3. Cytarabine 15 mg/m2 twice a day (subcutaneous injection), days 4-17

"Ven-DAC/AZA"

1. Venetoclax 400 mg once daily (PO), days 1-28
2. Either Azacitidine or Decitabine Azacitidine 75 mg/m2 (subcutaneous injection), days 1-7 Decitabine 20 mg/m2 (IV in 60 minutes). days 1-5

"5+5" regimen

1. Cytarabine 50 mg/m2 twice a day (subcutaneous injection), days 1-5
2. Mercaptopurine 30 mg/m2 twice a day (PO), days 1-5

Conditions

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AML

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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allo-HSCT

Patients with AML in CR1, MRD-negative after first course recieve allo-HSCT

Group Type EXPERIMENTAL

allo-HSCT

Intervention Type PROCEDURE

allo-HSCT from any type of donor

Chemo

Patients with AML in CR1, MRD-negative after first course continue chemotherapy

Group Type ACTIVE_COMPARATOR

allo-HSCT

Intervention Type PROCEDURE

allo-HSCT from any type of donor

Interventions

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allo-HSCT

allo-HSCT from any type of donor

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Newly diagnosed, previously untreated AML;
2. Age from 18 to 59 years;
3. Somatic status - ECOG \< 3.

Exclusion Criteria

1. previous chemotherapy for AML;
2. pregnancy;
3. relapses and refractory forms of AML;
4. acute promyelocytic leukemia;
5. blast crisis of chronic myeloid leukemia;
6. de novo AML with t(9;22);
7. AML transformed from MDS or MPN after treatment, for which a different protocol is provided;
8. Blastoid plasmacytoid dendritic cell neoplasia (with the exception of cases when a small population of plasmacytoid dendritic progenitors is detected in the leukemic neoplasia).
9. Undifferentiated acute leukemia

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No