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A Prospective Multicenter Clinical Trial of MRD-based Treatment Strategy in Children and Young Adults With AML

NCT03846362 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-03-16

No results posted yet for this study

Summary

Minimal-residual disease (MRD) will be measured either by flow cytometry, or polymerase chain reaction (PCR) methods, in 3 check-points and it will be one of the 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 Human Leucocyte Antigen (HLA) matched or haploidentical family donors.

Conditions

  • Acute Myeloid Leukemia, Childhood

Interventions

OTHER

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

Sponsors & Collaborators

  • Physicians, Innovations, Science for Children Fund

    collaborator UNKNOWN

  • Federal Research Institute of Pediatric Hematology, Oncology and Immunology

    lead OTHER

Principal Investigators

  • Alexey Maschan · National Research Center for Pediatric Hematology , Moscow, Russian Federation

  • Michael Maschan · National Research Center for Pediatric Hematology , Moscow, Russian Federation

  • Galina Novichkova · National Research Center for Pediatric Hematology , Moscow, Russian Federation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2023-12-31
Completion
2025-01-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846362 on ClinicalTrials.gov