Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04687098
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2020-12-18
Brief Title:
Risk-adapted Therapy for Primary Acute Myeloid Leukemia
Sponsor:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Organization:
Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias
Study Overview
Official Title:
Risk-adapted Therapy for Primary Acute Myeloid Leukemia AML in Adult Patients up to 70 Years Old
Status:
COMPLETED
Status Verified Date:
2023-06
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:
The AML-12 study investigates the efficacy and toxicity of standard induction chemotherapy with idarubicin and cytarabine IC with G-CSF priming followed by a risk-adapted post remission therapy for patients up to the age of 70 diagnosed with de novo acute myeloid leukemia AML
Modifications from the previous protocol AML-03 NCT01723657 include removal of etoposide in induction limitation of the GCSF priming to the induction phase and categorization of post remission therapy stem cell transplant or 2 high dose cytarabine consolidations according to diagnostic genetics as well as post-remission clearance of measurable residual disease
The aims of these modifications are to improve the overall survival and leukemia free survival of acute myeloid leukemia patients with a risk-adapted approach
Modifications from the previous protocol AML-03 NCT01723657 include removal of etoposide in induction limitation of the GCSF priming to the induction phase and categorization of post remission therapy stem cell transplant or 2 high dose cytarabine consolidations according to diagnostic genetics as well as post-remission clearance of measurable residual disease
The aims of these modifications are to improve the overall survival and leukemia free survival of acute myeloid leukemia patients with a risk-adapted approach
Detailed Description:
Induction chemotherapy Idarubicin 12mgm2day intravenous days 1-3 Low-dose cytarabine 200mgm2day intravenous in continuous infusion days 1-7 and G-CSF priming 150mcgm2day subcutaneous from day 0 to the last day of chemotherapy if white blood cell count WBC 30x10E9L
This induction chemotherapy can be repeated twice in the case of partial response PR to achieve complete response CR
Once CR is achieved with one or two induction cycles all patients receive a consolidation course with high-dose cytarabine 3000mgm212h days 1 3 and 5 and pegfilgrastim 6mg on day 6
After this patients will be allocated to the different risk groups as follows
Favorable risk group patients with t821q22q22RUNX1RUNX1T1 inv16p12q22 or t1616CBFBMYH11 Intermediate risk cytogenetics MRC 2010 and NPM1 mutation with FLT3 wild type or low ratio of FLT3 internal tandem duplication ITDwild type 05 or CEBPA biallelic mutation Patients in this group will receive 2 additional courses of consolidation therapy
Intermediate risk group Intermediate risk cytogenetics MRC 2010 without NPM1 mutations FLT3-ITD or CEBPA biallelic mutation Patients in this group receive an allogeneic stem cell transplant in first CR Patients without an available donor can be autografted per center decision
Adverse risk group Adverse risk cytogenetics MRC 2010 intermediate cytogenetics with FLT3-ITD without NPM1 mutation or NPM1-FLT3-ITD high ratio or MLL rearrangement any favorable or intermediate risk patients with positive MRD following 1 intermediate or 2 favorable consolidation courses Intention to treat of those patients is allogeneic stem cell transplant from any source
This induction chemotherapy can be repeated twice in the case of partial response PR to achieve complete response CR
Once CR is achieved with one or two induction cycles all patients receive a consolidation course with high-dose cytarabine 3000mgm212h days 1 3 and 5 and pegfilgrastim 6mg on day 6
After this patients will be allocated to the different risk groups as follows
Favorable risk group patients with t821q22q22RUNX1RUNX1T1 inv16p12q22 or t1616CBFBMYH11 Intermediate risk cytogenetics MRC 2010 and NPM1 mutation with FLT3 wild type or low ratio of FLT3 internal tandem duplication ITDwild type 05 or CEBPA biallelic mutation Patients in this group will receive 2 additional courses of consolidation therapy
Intermediate risk group Intermediate risk cytogenetics MRC 2010 without NPM1 mutations FLT3-ITD or CEBPA biallelic mutation Patients in this group receive an allogeneic stem cell transplant in first CR Patients without an available donor can be autografted per center decision
Adverse risk group Adverse risk cytogenetics MRC 2010 intermediate cytogenetics with FLT3-ITD without NPM1 mutation or NPM1-FLT3-ITD high ratio or MLL rearrangement any favorable or intermediate risk patients with positive MRD following 1 intermediate or 2 favorable consolidation courses Intention to treat of those patients is allogeneic stem cell transplant from any source
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?:
False
Is an FDA AA801 Violation?:
None