A Prospective Multicenter Clinical Trial of MRD-based Treatment Strategy in Children and Young Adults With AML
NCT ID: NCT03846362
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
500 participants
INTERVENTIONAL
2019-04-01
2025-01-31
Brief Summary
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Patients with initially high-risk group and those with high MRD after 2 initial courses of chemotherapy will be assigned to the allogenic transplantation of the hematopoietic stem cells from Human Leucocyte Antigen (HLA) matched or haploidentical family donors.
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Detailed Description
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Besides genetic factors, detection of the minimal residual disease (MRD) after initial chemotherapy and its decrease rate after 1st postremission chemotherapy with high dose Cytarabine and anthracyclines, plays a crucial role in the development of the morphologic relapse. Patients with PCR-MRD\<0,1% after 2 courses of chemotherapy have a 30% or less risk of relapse, while PCR-MRD\>0,1% - over 70%. In the clinical trial investigators are planning to measure MRD either by immune-phenotype, or PCR methods, in 3 check-points and it will be one of decision-making control parameter for the optimal therapy tactics.
Patients with initially high-risk group and those with high MRD after 2 initial courses of chemotherapy will be assigned to the allogenic transplantation of the hematopoietic stem cells from HLA- matched or haploidentical family donors.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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intermediate risk MRD2>0,1%
MRD2\>0,1% - FLA - MRD3 - HSCT
HSCT
allogenic HSCT from 5-8 HLA-MM family donor as a first choice for patients with initial high risk of relapse and for patients with MRD2\>0,1% and initial intermediate risk
Interventions
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HSCT
allogenic HSCT from 5-8 HLA-MM family donor as a first choice for patients with initial high risk of relapse and for patients with MRD2\>0,1% and initial intermediate risk
Eligibility Criteria
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Inclusion Criteria
2. signed informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Physicians, Innovations, Science for Children Fund
UNKNOWN
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
OTHER
Responsible Party
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Principal Investigators
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Alexey Maschan
Role: PRINCIPAL_INVESTIGATOR
National Research Center for Pediatric Hematology , Moscow, Russian Federation
Michael Maschan
Role: STUDY_DIRECTOR
National Research Center for Pediatric Hematology , Moscow, Russian Federation
Galina Novichkova
Role: STUDY_CHAIR
National Research Center for Pediatric Hematology , Moscow, Russian Federation
Locations
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Regional Children's Clinical Hospital № 1
Yekaterinburg, Sverdlovsk Oblast, Russia
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Oleg Arakaev
Role: primary
Other Identifiers
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NCPHOI-2018-05
Identifier Type: -
Identifier Source: org_study_id
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