Status:
RECRUITING
The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission
Lead Sponsor:
National Research Center for Hematology, Russia
Collaborating Sponsors:
Botkin Hospital
St. Petersburg State Pavlov Medical University
Conditions:
AML
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief 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...
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), day...
Eligibility Criteria
Inclusion
- Newly diagnosed, previously untreated AML;
- Age from 18 to 59 years;
- Somatic status - ECOG \< 3.
Exclusion
- previous chemotherapy for AML;
- pregnancy;
- relapses and refractory forms of AML;
- acute promyelocytic leukemia;
- blast crisis of chronic myeloid leukemia;
- de novo AML with t(9;22);
- AML transformed from MDS or MPN after treatment, for which a different protocol is provided;
- Blastoid plasmacytoid dendritic cell neoplasia (with the exception of cases when a small population of plasmacytoid dendritic progenitors is detected in the leukemic neoplasia).
- Undifferentiated acute leukemia
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05339204
Start Date
February 1 2021
End Date
February 1 2026
Last Update
April 21 2022
Active Locations (1)
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1
National Research Center for Hematology
Moscow, Russia