NCT05339204

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: National Research Center for Hematology, Russia · Network
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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.

Detailed description

"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

• AML

Interventions

Type	Name	Description
PROCEDURE	allo-HSCT	allo-HSCT from any type of donor

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2022-04-21
• Last updated: 2022-04-21

Locations

1 site across 1 country: Russia