NCT05339204

Brief 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.

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
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

5 years

First QC Date

April 14, 2022

Last Update Submit

April 14, 2022

Conditions

AML

Keywords

AML, MRD, allo-HSCT, CR1, adult

Outcome Measures

Primary Outcomes (2)

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

    5 years

  • Relapse probability

    5 years

Secondary Outcomes (2)

  • Overall survival

    5 years

  • Disease-free survival

    5 years

Study Arms (2)

allo-HSCT

EXPERIMENTAL

Patients with AML in CR1, MRD-negative after first course recieve allo-HSCT

Procedure: allo-HSCT

Chemo

ACTIVE COMPARATOR

Patients with AML in CR1, MRD-negative after first course continue chemotherapy

Procedure: allo-HSCT

Interventions

allo-HSCTPROCEDURE

allo-HSCT from any type of donor

Chemoallo-HSCT

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Newly diagnosed, previously untreated AML;
  • Age from 18 to 59 years;
  • Somatic status - ECOG \< 3.

You may not qualify if:

  • previous chemotherapy for AML;
  • pregnancy;
  • relapses and refractory forms of AML;
  • acute promyelocytic leukemia;
  • blast crisis of chronic myeloid leukemia;
  • de novo AML with t(9;22);
  • AML transformed from MDS or MPN after treatment, for which a different protocol is provided;
  • Blastoid plasmacytoid dendritic cell neoplasia (with the exception of cases when a small population of plasmacytoid dendritic progenitors is detected in the leukemic neoplasia).
  • Undifferentiated acute leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Center for Hematology

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Irina Lukianova, MD PhD

CONTACT

+79653493473Irina.donskova99@mail.ru

Anastasia Kashlakova, MD

CONTACT

+74956124592salvatorvaltz@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2022

First Posted

April 21, 2022

Study Start

February 1, 2021

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

Locations

RU(1)