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
National Research Center for Hematology, Russia·ClinicalTrials.gov·procedureRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
AML
Drug/Device/Intervention
allo-HSCT
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
National Research Center for Hematology, Russia
Location
Moscow, Russian Federation
Timeline & enrollment
Phase
N/A
Start date
Feb 01, 2021
End date
Feb 01, 2026
Enrollment
75 participants
Primary outcome

Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo,Relapse probability

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.

ICD-10 classifications
Acute myeloblastic leukaemia [AML]
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05339204
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05339204 through Pure Global AI's free database. This phase not specified trial is sponsored by National Research Center for Hematology, Russia and is currently Recruiting. The study focuses on AML. Target enrollment is 75 participants.

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