NCT03846362

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2019

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

4.7 years

First QC Date

February 14, 2019

Last Update Submit

March 15, 2023

Conditions

Acute Myeloid Leukemia, Childhood

Keywords

AMLMRDstem cell transplantationpediatricleukemiahaploidenticalTcRab-depletionyoung adult

Outcome Measures

Primary Outcomes (1)

  • relapse-free survival (RFS)

    relapse-free survival from date of diagnosis till date of relapse, or date of death (whichever comes first) or date of last follow up

    1 year

Secondary Outcomes (11)

  • overall survival (OS)

    1 year

  • event-free survival (EFS)

    2 years

  • The proportion of of patients with severe adverse effects

    6 months

  • The proportion of of patients with severe infections

    1 month

  • The proportion of of patients with severe cardiotoxicity

    1 year

  • +6 more secondary outcomes

Study Arms (1)

intermediate risk MRD2>0,1%

EXPERIMENTAL

MRD2\>0,1% - FLA - MRD3 - HSCT

Other: HSCT

Interventions

HSCTOTHER

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

intermediate risk MRD2>0,1%

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • de novo acute myeloid leukemia
  • signed informed consent

You may not qualify if:

  • diagnosis of: Fanconi anemia, acute promyelocytic leukemia, MDS, JMML, AML as secondary malignancy, Dawn syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regional Children's Clinical Hospital № 1

Yekaterinburg, Sverdlovsk Oblast, 620149, Russia

NOT YET RECRUITING

Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology

Moscow, 117198, Russia

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteLeukemia

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Alexey Maschan

    National Research Center for Pediatric Hematology , Moscow, Russian Federation

    PRINCIPAL INVESTIGATOR

  • Michael Maschan

    National Research Center for Pediatric Hematology , Moscow, Russian Federation

    STUDY DIRECTOR

  • Galina Novichkova

    National Research Center for Pediatric Hematology , Moscow, Russian Federation

    STUDY CHAIR

Central Study Contacts

Irina Kalinina

CONTACT

+7 495 287 65 70oml-registration@fnkc.ru

Zhanna Shekhovtsova

CONTACT

+7 495 287 65 70zhanna.shekhovtsova@fccho-moscow.ru

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 19, 2019

Study Start

April 1, 2019

Primary Completion

December 1, 2023

Study Completion

January 1, 2025

Last Updated

March 16, 2023

Record last verified: 2023-03

Locations

RU(2)