Acute Myeloid Leukemia Clinical Trial
Official title:
Evaluation of the Efficacy of Induction-consolidation Treatment Using a Double Induction in Patients With AML <60 Years Old, Depending on the Percentage of Blasts in the 14 Day, Residual Disease and Leukemic Hematopoietic Cells
In view of the diversity of the biology of acute myeloid leukemia (AML) therapy in
individual patients must be individualized. One of the tools for this is
molecular-cytogenetic stratification. It divides patients into five categories (prognostic
groups): Favorable, Intermediate-1, Intermediate-2, Adverse and Very adverse risk. After
remission proceedings are tailored depending on prognostic determined groups.
Research of PALG group in the application in the second line regimen CLAG and CLAG-M proved
high effectiveness of this treatment with low toxicity. Considering experience of PALG
groups, it seems that the use of the schema CLAG early as the second induction therapy is a
viable treatment option.
Patients with AML with one of 5 prognostic categories based on modified
cytogenetic-molecular stratification (European Leukemia Net Prognostic System - ENL)
Favorable risk
t(8;21)(q22;q22); RUNX1-RUNX1T1 inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11 Mutated
NPM1 without FLT3-ITD (NK) Mutated CEBPA (NK)
Intermediate I risk
Mutated NPM1 with FLT3-ITD (NK) Wild-type NPM1 and FLT3-ITD (NK) Wild-type NPM1 without
FLT3-ITD (NK)
Intermediate II risk
t(9;11)(p22;q22); MLLT3-MLL cytogenic abnormalities other than favorable or adverse
Adverse risk
Inv(3)(q21q26.2) or t(3;3)(q21;q26.2); RPN-EVI1
Very adverse risk monosomal karyotype (MK): -5 or del(5q); -7; abnl(17p); complex karyotype
Goals:
- Evaluation of the impact of therapy tailored to the risk factors on outcome of AML
patients aged ≤ 60.
- Evaluation of the possibility to improve the results of induction therapy through the
use of early 2nd induction in patients with persistent leukemic infiltration of the
bone marrow at the 14th day,
- Evaluation of the impact of the minimal residual disease (MRD) presence assessed by
Immunophenotyping method, on the results of treatment of AML patients aged ≤ 60,
- Assessing the significance of monitoring the number of leukemic stem cells (LSC) in
bone marrow and peripheral blood and their influence on clinical course and outcome of
AML treatment,
- Assessment of the LSC determination usefulness in MRD monitoring in patients with AML,
- Evaluation of the prognostic significance of the expression of CXCR-4 on the surface of
leukemic cells and their impact on the clinical course and outcome of AML - trying to
select a group of patients who potentially would benefit from the use of
chemosensitization with plerixafor,
- Evaluation of autologous HSCT effectiveness in consolidation therapy in AML patients
from 3 following cytogenetic-molecular risk groups: Favorable, Intermediate I,
Intermediate II,
- Comparison of the overall survive (OS) and leukemia-free survival after autologous and
allogeneic HSCT in AML patients from Intermediate I and Intermediate II
cytogenetic-molecular risk groups (biological randomization donor vs. donor).
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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