Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia

Study Overview
=================
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.

Official Title
-----------------
Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia

Conditions
-----------------
Acute Myeloid Leukemia, Pediatric

Intervention / Treatment
-----------------
* Other: Risk-stratified therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed AML Exclusion Criteria: children with Down's syndrome and acute promyelocytic leukemia (APL)

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CAMS-2005 trial<br>The induction course was Daunorubicin(DNR) + Cytarabine(Ara-C) or Homoharringtonine(HHT) + Ara-C or HHT + DNR + Ara-C. There are 5 consolidation course after complete remission (CR). | |
| CAMS-2009 trial<br>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. | Other: Risk-stratified therapy<br>* Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival (OS) | overall survival | From date of diagnosed until the date of death from any cause, assessed up to 60 months | 
| event-free survival (EFS) | event-free survival | 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 | 
| complete remission (CR) | fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI) | through study completion, an average of 1 year |