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: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• Newly diagnosed, previously untreated AML;

• Age from 18 to 59 years;

• Somatic status - ECOG \< 3.

Locations
Other Locations
Russian Federation
National Research Center for Hematology
RECRUITING
Moscow
Contact Information
Primary
Irina Lukianova, MD PhD
Irina.donskova99@mail.ru
+79653493473
Backup
Anastasia Kashlakova, MD
salvatorvaltz@gmail.com
+74956124592
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2026-02-01
Participants
Target number of participants: 75
Treatments
Experimental: allo-HSCT
Patients with AML in CR1, MRD-negative after first course recieve allo-HSCT
Active_comparator: Chemo
Patients with AML in CR1, MRD-negative after first course continue chemotherapy
Related Therapeutic Areas
Sponsors
Collaborators: Clinical hospital №1 of Sverdlovsk region, Botkin Hospital, Regional Clinical Hospital of Yaroslavl, Irkutsk regional clinical hospital, winner of the Mark of the Honor award, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, The Federal State-Financed Scientific Institution Kirov Research Institute of Hematology and Blood T, Nizhny Novgorod regional clinical hospital named after N.A.Semashko, St. Petersburg State Pavlov Medical University, Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Leads: National Research Center for Hematology, Russia

This content was sourced from clinicaltrials.gov

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