Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06221683
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-01-04
Brief Title:
Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML
Sponsor:
Childrens Hospital of Soochow University
Organization:
Childrens Hospital of Soochow University
Study Overview
Official Title:
A Multicenter Clinical Study of Molecular Subtyping Combined With MRD-driven Remission Induction Regimen in Children and Adolescents With AML A Phase II Cohort Study GMCAII
Status:
RECRUITING
Status Verified Date:
2024-08
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:
GMCAII
Brief Summary:
The goal of this clinical trial is to estimate the rate probability of complete remission or complete remission with incomplete count recovery CRCRi with negative MRD after induction I and II event-free survival EFS and cumulative incidence probability of relapse CIR in patients receiving molecularprecision medicine and MRD-driven remission inductions and to assess secondarily if there is an improvement over the AML2018 protocol
Detailed Description:
Advances in risk stratification and therapy have improved the event-free survival EFS and overall survival OS for pediatric acute myeloid leukemia AML with current treatment strategies Investigators previously conducted a multicenter randomized controlled trial AML18 to compare the efficacy and safety of low-dose chemotherapy versus standard-dose chemotherapy The results showed that low-dose chemotherapy was non-inferior to standard-dose chemotherapy in terms of efficacy and had fewer adverse events However different subtypes exhibited varying treatment responses to both chemotherapy regimens The MRD Measurable Residual Disease after induction therapy in both groups had an impact on prognosis According to the backbone of the 2018 protocol investigators decide whether to use low-dose or standard-dose for the first induction according to the patients fusion gene and the second induction and subsequent treatment are adjusted according to the treatment response Patients with the following 5 fusion genes RUNX1 RUNX1T1 CBFβ MYH11 KMT2A MLLT3 AF9 KMT2A MLLT10 AF10 KMT2A MLLT4 AF6 fusion or KIT mutation will be assigned to the standard dose remission induction regimen HHT Ara-C VP16 others will be assigned to the standard dose regimen MitoxantroneIdarubicin Ara-C G-CSF At the same time investigators will add targeted drugs such as venetoclax avaptitinib and gilteritinibsorafenib to the chemotherapy regimen and assess their safety and efficacy Post-induction consolidation consisted of 3 to 4 cycles of standard-dose chemotherapy according to risk classification Patients classified as high-risk are candidates for allogeneic bone marrow transplantation after 1 or 2 courses of consolidation
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