The Efficiency of CAMS (Chinese Academy of Medical Sciences)-2016 Trial for Pediatric Acute Myeloid Leukemia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate that whether the AML (acute myeloid leukemia)-CAMS (Chinese Academy of Medical Sciences)-2016 regimen, includes risk-stratified therapy and the use of Dasatinib in CBF (Core binding factor)-AML, can improve the outcome in childhood AML.

Detailed Description
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Primary AML includes CBF(Core binding factor)-AML and non-CBF-AML. After the second course of therapy, CBF-AML are stratified into two risk groups: low-risk children are defined as those with CR after MAE or CAG, high-risk children are those with CR after consolidation course 1 or IAE. Non-CBF-AML patients in remission are stratified into three risk groups: low-risk children are defined as those with t(1；11)(q21；q23) , GATA1, NPM1/IDH1/IDH2 without FLT3/ITD,or an age younger than 2 years without high-risk factors; high-risk children are those with CR after consolidation course 1 or IAE or with abnormalities of monosomy 7, 5q- , t(16;21), t(9;22) (Philadelphia chromosome [Ph1]), FLT3/ITD,-17/TP53, RPN1-MECOM, RUNX1-EVI1, MLF1-NPM1, PRDM16-RPN1, DEK-NUP214, ETV6(TEL)-HLXB9(MNX1), NUP98-NSD1; intermediate-risk children are those who were not in either a low-risk or high-risk group.Low-risk children were treated only with chemotherapy, regardless the availability of a suitable HSCT donor. All high-risk children were allocated to Allo-hematopoietic stem cell transplantation (HSCT) in the first remission, including unrelated bone marrow transplantation (BMT). Auto-HSCT is recommended for intermediate-risk children. No prophylactic cranial irradiation is included in the protocol. Patients are treated on an inpatient basis during each treatment phase.

Official Title
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The Efficiency of CAMS-2016 Trial for the Newly Diagnosed Pediatric Acute Myeloid Leukemia: A Prospective Single Centre Trial From China

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Dasatinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newly diagnosis of de novo Acute Myeloid Leukemia Exclusion Criteria: Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AML-CAMS-2016 trial<br>AML-CAMS-2016 regimen includes risk-stratified therapy and the use of Dasatinib in CBF-AML.The induction regimen includes MAE (etoposide 150mg/㎡/d d1-5, cytarabine 200mg/㎡/d d6-12 , mitoxantrone 5 mg/㎡/d d6-10), CAG (aclacinomycin 6mg/㎡/d d1-8, Ara-C 10mg/㎡ q12h d1-14 , G-CSF 200ug/㎡/d d1-14),IAE (idarubicin 8 mg/㎡/d d1-3, Ara-C 500mg/㎡/d d1-3 d8-10, VP-16 200mg/㎡/d d8-10).Consolidation regimen includes IA (Ara-C 1g/㎡ q12h d1-4, IDA 10mg/㎡/d d1), MA (Ara-C 1g/㎡ q12h d1-4, MTZ 5mg/㎡/d d1-3), IAE (IDA 10mg/㎡/d d1, Ara-C 3g/㎡ q12h d1-3, VP-16 100mg/㎡/d d1-5), MAE (Ara-C 200mg/㎡ d4-8, VP-16 150mg/㎡/d d1-3, MTZ 5mg/㎡/d d4-6),EA (Ara-C 2g/㎡ q12h d1-5, VP-16 100mg/㎡/d d1-5),IAE (IDA 10mg/㎡/d d1, Ara-C 3g/㎡ q12h d1-3, VP-16 100mg/㎡/d d1-5),EA (Ara-C 2g/㎡ q12h d1-5, VP-16 100mg/㎡/d d1-5),MAE (Ara-C 200mg/㎡ d4-8, VP-16 150mg/㎡/d d1-3, MTZ 5mg/㎡/d d4-6). Dasatinib (60-80mg/㎡) is used in CBF-AML as a part of consolidation therapy. | Drug: Dasatinib<br>* Primary AML includes CBF-AML and non-CBF-AML. Children with a WBC (white blood cell) lower than 4,000/μL and low proliferative bone marrow at diagnosis are treated with CAG. Other children are treated with MAE. The rescue regimen for children who showed M3 marrow after MAE or CAG is IAE. Consolidation therapy consisted of four (for CBF-AML) or five (for non-CBF-AML) courses, and triplein trathecal therapy is given as a part of each course. After the second course of therapy, CBF-AML are stratified into two risk groups, while non-CBF-AML patients in remission are stratified into three risk groups.Consolidation regimen for CBF-AML includes IA, MA, IA, MA. Dasatinib is used in CBF-AML as a part of consolidation therapy. Consolidation regimen for non-CBF-AML includes IAE, MAE, EA, IAE, EA or MAE.<br>* Other names: Mitoxantrone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission | Fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI) | through study completion, an average of 7 year | 
| 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 | 
| Disease-free Survival (DFS) | Disease-free Survival | From date of remission until the date of first relapse or date of death from any cause, whichever came first, assessed up to 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality | Dead during the treatment | one year after diagnosed |