The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission
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- STATUS
- Recruiting
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- End date
- Feb 1, 2026
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- participants needed
- 75
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- sponsor
- National Research Center for Hematology, Russia
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.
Description
"7+3" regimen:
- Cytarabine 200 mg/m2 (IV continuous infusion over 24 hours), days 1-7
- Daunorubicin 60 mg/m2 (IV bolus), days 1-3
"FLAG" regimen:
- Fludarabine 25 mg/m2 (IV in 30 minutes), days 1-5
- Cytarabine 1500 mg/m2 (IV in 3 hours), days 1-5
- Granulocyte colony-stimulating factor 5 mcg/kg (subcutaneous injection), from day 6 until regression of cytopenia
"Aza-Ida-Ara-C" regimen:
- Azacitidine 75 mg/m2 (subcutaneous injection), days 1-3
- Idarubicin 3 mg/m2 (IV bolus), days 4-10
- Cytarabine 15 mg/m2 twice a day (subcutaneous injection), days 4-17
"Ven-DAC/AZA"
- Venetoclax 400 mg once daily (PO), days 1-28
- 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
- Cytarabine 50 mg/m2 twice a day (subcutaneous injection), days 1-5
- Mercaptopurine 30 mg/m2 twice a day (PO), days 1-5
Details
| Condition | AML |
|---|---|
| Treatment | Allo-HSCT |
| Clinical Study Identifier | NCT05339204 |
| Sponsor | National Research Center for Hematology, Russia |
| Last Modified on | 28 April 2022 |
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