Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia

Institute of Hematology & Blood Diseases Hospital, China

Status: Completed

Conditions: Acute Myeloid Leukemia, Pediatric

Treatments: Other: Risk-stratified therapy

Study type: Observational

Funder types: Other

Identifiers

NCT03165851

RE2016001-EC-1

Details and patient eligibility

About

The investigators adopted the CAMS（Chinese Academy of Medical Sciences）-2009 trial for pediatric acute myeloid leukemia (AML) patients between 2009 to 2015, in which a risk-stratified strategy and dose-dense intensive chemotherapy were introduced. The outcomes of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.

Enrollment: 320 patients

Sex: All

Ages: 6 months to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed AML

Exclusion criteria

• children with Down's syndrome and acute promyelocytic leukemia (APL)

Trial design

320 participants in 2 patient groups

CAMS-2005 trial

Description:

The induction course was Daunorubicin(DNR) + Cytarabine(Ara-C) or Homoharringtonine(HHT) + Ara-C or HHT + DNR + Ara-C. There are 5 consolidation course after complete remission (CR).

CAMS-2009 trial

Description:

The induction course was MAE(Mitoxantrone + Cytarabine + Etoposide) or IAE(Idamycin + Cytarabine + Etoposide). Risk-stratified therapy and dose-dense intensive chemotherapy were adopted in the consolidation therapy. After the second course of therapy, patients in remission were stratified into three risk groups: low-risk children were defined as those with t(8;21) and a white blood cell count lower than 50,000/L, inv(16), or an age younger than 2 years without any high-risk factors; high-risk children were those with CR after consolidation course 1 or induction C , or with abnormalities of monosomy 7, 5q-, t(16;21), t(9;22)(Philadelphia chromosome \[Ph1\]); intermediate-risk children were those who were not in either a low-risk or high-risk group. Hematopoietic stem cell transplantation (HSCT) was indicated for only relapsed patients in the second CR.

Treatment:

Other: Risk-stratified therapy