The Efficiency of CAMS (Chinese Academy of Medical Sciences)-2016 Trial for Pediatric Acute Myeloid Leukemia
- Registration Number
- NCT03173612
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 132
- Newly diagnosis of de novo Acute Myeloid Leukemia
- Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AML-CAMS-2016 trial Dasatinib 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.
- Primary Outcome Measures
Name Time Method Complete remission through study completion, an average of 7 year Fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
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
Disease-free Survival (DFS) 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 Disease-free Survival
- Secondary Outcome Measures
Name Time Method all cause mortality one year after diagnosed Dead during the treatment
Trial Locations
- Locations (1)
InstituteHBDH
🇨🇳Tianjin, Tianjin, China