Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516679
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-06-27
Brief Title:
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Risk-Stratified Treatment in Newly Diagnosed Infant Leukemia A Multicenter Prospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial is an open-label multicenter prospective phase 2 clinical trial targeting pediatric leukemia patients of infant age The goal is to improve survival rates by varying the presence or absence of chemotherapy and hematopoietic stem cell transplantation based on genetic characteristics at the time of diagnosis and minimal residual disease MRD values measured by various methods after treatment
In addition by clearly defining the patient group that requires hematopoietic stem cell transplantation it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia for which there have been various guidelines for hematopoietic stem cell transplantation can be confirmed Additionally due to the characteristics of infants this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment
In addition by clearly defining the patient group that requires hematopoietic stem cell transplantation it is expected that the role of hematopoietic stem cell transplantation in infantile leukemia for which there have been various guidelines for hematopoietic stem cell transplantation can be confirmed Additionally due to the characteristics of infants this study aim to identify long-term sequelae or prognosis related to treatment by prospectively collecting side effect data related to treatment during and after treatment
Detailed Description:
Infant leukemia patients are classified into lowintermediatehigh risk groups and hematopoietic stem cell transplantation is performed after chemotherapy or chemotherapy as shown in the schema below
Low risk group Induction chemotherapy-Low Risk Consolidation chemotherapy 14 - Maintenance chemotherapy
Intermediate risk group Induction chemotherapy-High Risk Consolidation chemotherapy 14 - Maintenance chemotherapy
High risk group Induction chemotherapy-High Risk Consolidation chemotherapy 14 - hematopoietic stem cell transplantation
Low risk group Induction chemotherapy-Low Risk Consolidation chemotherapy 14 - Maintenance chemotherapy
Intermediate risk group Induction chemotherapy-High Risk Consolidation chemotherapy 14 - Maintenance chemotherapy
High risk group Induction chemotherapy-High Risk Consolidation chemotherapy 14 - hematopoietic stem cell transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None