Acute Myeloid Leukemia
Conditions
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.
Interventions
DRUGDasatinib
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.
Sponsors
Institute of Hematology & Blood Diseases Hospital, China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No
Inclusion criteria
* Newly diagnosis of de novo Acute Myeloid Leukemia
Exclusion criteria
* Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| all cause mortality | one year after diagnosed | Dead during the treatment |
Countries
China
Contacts
Primary ContactZhu Xiaofan
Outcome results
None listed