Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
Completed
- Conditions
- Acute Myeloid Leukemia, Pediatric
- Interventions
- Other: Risk-stratified therapy
- Registration Number
- NCT03165851
- Brief Summary
The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
- newly diagnosed AML
Exclusion Criteria
- children with Down's syndrome and acute promyelocytic leukemia (APL)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CAMS-2009 trial Risk-stratified therapy The induction course was MAE(Mitoxantrone + Cytarabine + Etoposide) or IAE(Idamycin + Cytarabine + Etoposide). Risk-stratified therapy and dose-dense intensive chemotherapy were adopted in the consolidation therapy. After the second course of therapy, patients in remission were stratified into three risk groups: low-risk children were defined as those with t(8;21) and a white blood cell count lower than 50,000/L, inv(16), or an age younger than 2 years without any high-risk factors; high-risk children were those with CR after consolidation course 1 or induction C , or with abnormalities of monosomy 7, 5q-, t(16;21), t(9;22)(Philadelphia chromosome \[Ph1\]); intermediate-risk children were those who were not in either a low-risk or high-risk group. Hematopoietic stem cell transplantation (HSCT) was indicated for only relapsed patients in the second CR.
- Primary Outcome Measures
Name Time Method overall survival (OS) From date of diagnosed until the date of death from any cause, assessed up to 60 months overall survival
event-free survival (EFS) From date of diagnosed until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months event-free survival
complete remission (CR) through study completion, an average of 1 year fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
InstituteHBDH
🇨🇳Tianjin, Tianjin, China