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

Last updated: August 2, 2022
Sponsor: Institute of Hematology & Blood Diseases Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT03173612
AML-CAMS-2016
  • Ages 6-16
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosis of de novo Acute Myeloid Leukemia

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 132
Study Start date:
August 01, 2016
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • InstituteHBDH

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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