AMLNCT05339204
The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission
A study testing allo-HSCT in people with AML, run by National Research Center for Hematology, Russia at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- AML
- What is being tested?
- allo-HSCT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteRussia
- Study dates
- 1 Feb 2021to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed, previously untreated AML;
- Age from 18 to 59 years;
- Somatic status - ECOG < 3.
Who cannot join
- 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);
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- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
National Research Center for Hematology
Moscow
Elena Parovichnikova
About this study
Official title: Prospective Multicenter Randomized Controlled Clinical Trial for Evaluation the Role of Allo-HSCT in the First Complete Remission, MRD-negative After the First Course, in Patients With AML Under the Age of 60 Years
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.
Read the detailed description
"7+3" regimen:
- Cytarabine 200 mg/m2 (IV continuous infusion over 24 hours), days 1-7
- Daunorubicin 60 mg/m2 (IV bolus), days 1-3
"FLAG" regimen:
- Fludarabine 25 mg/m2 (IV in 30 minutes), days 1-5
- Cytarabine 1500 mg/m2 (IV in 3 hours), days 1-5
- Granulocyte colony-stimulating factor 5 mcg/kg (subcutaneous injection), from day 6 until regression of cytopenia
"Aza-Ida-Ara-C" regimen:
- Azacitidine 75 mg/m2 (subcutaneous injection), days 1-3
- Idarubicin 3 mg/m2 (IV bolus), days 4-10
- Cytarabine 15 mg/m2 twice a day (subcutaneous injection), days 4-17
"Ven-DAC/AZA"
- Venetoclax 400 mg once daily (PO), days 1-28
- Either Azacitidine or Decitabine Azacitidine 75 mg/m2 (subcutaneous injection), days 1-7 Decitabine 20 mg/m2 (IV in 60 minutes). days 1-5
"5+5" regimen
- Cytarabine 50 mg/m2 twice a day (subcutaneous injection), days 1-5
- Mercaptopurine 30 mg/m2 twice a day (PO), days 1-5
- Conditions
- AML
- Being tested
- allo-HSCT
- Keywords
- AML, MRD, allo-HSCT, CR1, adult
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allo-HSCTProcedure or surgery
allo-HSCT from any type of donor
| Study group | Role | What they receive |
|---|---|---|
| allo-HSCT | Experimental | Patients with AML in CR1, MRD-negative after first course recieve allo-HSCT Receives: Procedure: allo-HSCT |
| Chemo | Active comparator | Patients with AML in CR1, MRD-negative after first course continue chemotherapy Receives: Procedure: allo-HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo
Measured: 5 years
Relapse probability
Measured: 5 years
Secondary outcomes (2)
Overall survival
Measured: 5 years
Disease-free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Feb 2021
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Research Center for Hematology, Russia
- Sponsor type
- Research network
- Collaborators
- Botkin Hospital, St. Petersburg State Pavlov Medical University, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Federal Research Clinical Center of Federal Medical & Biological Agency, Russia, Regional Clinical Hospital of Yaroslavl, Nizhny Novgorod regional clinical hospital named after N.A.Semashko, Sverdlovsk Regional Clinical Hospital No.1, Irkutsk regional clinical hospital, winner of the "Mark of the Honor" award, The Federal State-Financed Scientific Institution Kirov Research Institute of Hematology and Blood T
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339204
- Sponsor's protocol ID
- AML-21
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Randomized Controlled Clinical Trial for Evaluation the Role of Allo-HSCT in the First Complete Remission, MRD-negative After the First Course, in Patients With AML Under the Age of 60 Years
- ClinicalTrials.gov ID
- NCT05339204
- Acronym / sponsor ID
- AML-21
- Conditions
- AML
- Keywords
- AML, MRD, allo-HSCT, CR1, adult
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- National Research Center for Hematology, RussiaResearch network
- Collaborators
- Botkin Hospital, St. Petersburg State Pavlov Medical University, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health, Federal Research Clinical Center of Federal Medical & Biological Agency, Russia, Regional Clinical Hospital of Yaroslavl, Nizhny Novgorod regional clinical hospital named after N.A.Semashko, Sverdlovsk Regional Clinical Hospital No.1, Irkutsk regional clinical hospital, winner of the "Mark of the Honor" award, The Federal State-Financed Scientific Institution Kirov Research Institute of Hematology and Blood T
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"7+3" regimen:
- Cytarabine 200 mg/m2 (IV continuous infusion over 24 hours), days 1-7
- Daunorubicin 60 mg/m2 (IV bolus), days 1-3
"FLAG" regimen:
- Fludarabine 25 mg/m2 (IV in 30 minutes), days 1-5
- Cytarabine 1500 mg/m2 (IV in 3 hours), days 1-5
- Granulocyte colony-stimulating factor 5 mcg/kg (subcutaneous injection), from day 6 until regression of cytopenia
"Aza-Ida-Ara-C" regimen:
- Azacitidine 75 mg/m2 (subcutaneous injection), days 1-3
- Idarubicin 3 mg/m2 (IV bolus), days 4-10
- Cytarabine 15 mg/m2 twice a day (subcutaneous injection), days 4-17
"Ven-DAC/AZA"
- Venetoclax 400 mg once daily (PO), days 1-28
- Either Azacitidine or Decitabine Azacitidine 75 mg/m2 (subcutaneous injection), days 1-7 Decitabine 20 mg/m2 (IV in 60 minutes). days 1-5
"5+5" regimen
- Cytarabine 50 mg/m2 twice a day (subcutaneous injection), days 1-5
- Mercaptopurine 30 mg/m2 twice a day (PO), days 1-5
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allo-HSCT | Experimental | Procedure: allo-HSCTPatients with AML in CR1, MRD-negative after first course recieve allo-HSCT |
| Chemo | Active comparator | Procedure: allo-HSCTPatients with AML in CR1, MRD-negative after first course continue chemotherapy |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Newly diagnosed, previously untreated AML;
- Age from 18 to 59 years;
- Somatic status - ECOG < 3.
Key exclusion criteria (9 listed)
- previous chemotherapy for AML;
- pregnancy;
- relapses and refractory forms of AML;
- acute promyelocytic leukemia;
- blast crisis of chronic myeloid leukemia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allo-HSCTallo-HSCT from any type of donor | Procedure or surgery | Chemo, allo-HSCT |
Primary outcome
Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo
Time frame: 5 years
Relapse probability
Time frame: 5 years
2 secondary outcomes
Overall survival
Time frame: 5 years
Disease-free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing allo-HSCT in people with AML, run by National Research Center for Hematology, Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irina Lukianova, MD PhD (+79653493473, Irina.donskova99@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival for AML in CR1 with MRD-negativity after first course of chemo (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.