Ignite Creation Date:
2024-05-06 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05339204
Status:
RECRUITING
Last Update Posted:
2022-04-21
First Post:
2022-04-14
Brief Title:
The Role of Allo-HSCT in MRD-negative Patients With AML Under the Age of 60 Years in the First Complete Remission
Sponsor:
National Research Center for Hematology Russia
Organization:
National Research Center for Hematology Russia
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inv16p131q22 or t1616p131q22 CBFB-MYH11 group B - AML with t821q22q221 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 AC group C - AML with myelodysplasia-related changes Patients from group A receive treatment according to the scheme 2 courses 73 2 courses FLAG then - 6 courses of maintenance therapy according to the scheme 55 Patients from group B are given one course of 73 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 73 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:
73 regimen
1 Cytarabine 200 mgm2 IV continuous infusion over 24 hours days 1-7
2 Daunorubicin 60 mgm2 IV bolus days 1-3
FLAG regimen
1 Fludarabine 25 mgm2 IV in 30 minutes days 1-5
2 Cytarabine 1500 mgm2 IV in 3 hours days 1-5
3 Granulocyte colony-stimulating factor 5 mcgkg subcutaneous injection from day 6 until regression of cytopenia
Aza-Ida-Ara-C regimen
1 Azacitidine 75 mgm2 subcutaneous injection days 1-3
2 Idarubicin 3 mgm2 IV bolus days 4-10
3 Cytarabine 15 mgm2 twice a day subcutaneous injection days 4-17
Ven-DACAZA
1 Venetoclax 400 mg once daily PO days 1-28
2 Either Azacitidine or Decitabine Azacitidine 75 mgm2 subcutaneous injection days 1-7 Decitabine 20 mgm2 IV in 60 minutes days 1-5
55 regimen
1 Cytarabine 50 mgm2 twice a day subcutaneous injection days 1-5
2 Mercaptopurine 30 mgm2 twice a day PO days 1-5
1 Cytarabine 200 mgm2 IV continuous infusion over 24 hours days 1-7
2 Daunorubicin 60 mgm2 IV bolus days 1-3
FLAG regimen
1 Fludarabine 25 mgm2 IV in 30 minutes days 1-5
2 Cytarabine 1500 mgm2 IV in 3 hours days 1-5
3 Granulocyte colony-stimulating factor 5 mcgkg subcutaneous injection from day 6 until regression of cytopenia
Aza-Ida-Ara-C regimen
1 Azacitidine 75 mgm2 subcutaneous injection days 1-3
2 Idarubicin 3 mgm2 IV bolus days 4-10
3 Cytarabine 15 mgm2 twice a day subcutaneous injection days 4-17
Ven-DACAZA
1 Venetoclax 400 mg once daily PO days 1-28
2 Either Azacitidine or Decitabine Azacitidine 75 mgm2 subcutaneous injection days 1-7 Decitabine 20 mgm2 IV in 60 minutes days 1-5
55 regimen
1 Cytarabine 50 mgm2 twice a day subcutaneous injection days 1-5
2 Mercaptopurine 30 mgm2 twice a day PO days 1-5
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None