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NCT05339204
The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission
NA trial testing allo-HSCT in AML in 75 participants. Status unknown.
1 February 2026
Quick facts
| Lead sponsor | National Research Center for Hematology, Russia |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 1 February 2021 |
| Primary completion | 1 February 2026 |
| Estimated completion | 1 February 2026 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- allo-HSCT
Conditions studied
- AML — all drugs for AML →
Sponsor
National Research Center for Hematology, Russia — full company profile →
Who can join
Adults 18 to 59, any sex, with AML. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Publication Only
· 2025 -
EHA2024 Hybrid Congress
· 2024 -
PB1866: IS ALLO-HSCT IN CR1 NECESSARY FOR AML PATIENTS WITH MRD NEGATIVITY ACHIEVED AFTER THE FIRST INDUCTION COURSE? RUSSIAN PROSPECTIVE MULTICENTER RANDOMIZED TRIAL IN AML PATIENTS UNDER THE AGE OF 60
Parovichnikova E, Lukianova I, Galtzeva I, Kashlakova A, et al · · 2023
Verify or expand the search:
- PubMed search for NCT05339204
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05339204 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Center for Hematology, Russia
- Last refreshed: 21 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05339204.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing