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

  • STATUS
    Recruiting
  • End date
    Dec 11, 2022
  • participants needed
    132
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 23 February 2022
remission
consolidation therapy

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.

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(111)(q21q23) , 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.

Details
Condition Acute Myeloid Leukemia
Treatment dasatinib
Clinical Study IdentifierNCT03173612
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on23 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Newly diagnosis of de novo Acute Myeloid Leukemia

Exclusion Criteria

Children with Down's syndrome and acute promyelocytic leukemia, hybrid acute leukemia
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