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| Name | Class |
|---|---|
| Botkin Hospital | OTHER |
| St. Petersburg State Pavlov Medical University | OTHER |
| Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | OTHER |
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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.
"7+3" regimen:
"FLAG" regimen:
"Aza-Ida-Ara-C" regimen:
"Ven-DAC/AZA"
"5+5" regimen
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allo-HSCT | Experimental | Patients with AML in CR1, MRD-negative after first course recieve allo-HSCT |
|
| Chemo | Active Comparator | Patients with AML in CR1, MRD-negative after first course continue chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allo-HSCT | Procedure | allo-HSCT from any type of donor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo | 5 years | |
| Relapse probability | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years | |
| Disease-free survival | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Irina Lukianova, MD PhD | Contact | +79653493473 | Irina.donskova99@mail.ru | |
| Anastasia Kashlakova, MD | Contact | +74956124592 | salvatorvaltz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Research Center for Hematology | Recruiting | Moscow | Russia |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Federal Research Clinical Center of Federal Medical & Biological Agency, Russia | OTHER_GOV |
| Regional Clinical Hospital of Yaroslavl | UNKNOWN |
| Nizhny Novgorod regional clinical hospital named after N.A.Semashko | UNKNOWN |
| Sverdlovsk Regional Clinical Hospital No.1 | NETWORK |
| Irkutsk regional clinical hospital, winner of the "Mark of the Honor" award | UNKNOWN |
| The Federal State-Financed Scientific Institution Kirov Research Institute of Hematology and Blood T | OTHER_GOV |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |