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

NCT ID: NCT03165851

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

320 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-10

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myeloid Leukemia, Pediatric

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CAMS-2005 trial

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).

No interventions assigned to this group

CAMS-2009 trial

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.

Risk-stratified therapy

Intervention Type OTHER

Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.

Interventions

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Risk-stratified therapy

Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* newly diagnosed AML

Exclusion Criteria

* children with Down's syndrome and acute promyelocytic leukemia (APL)
Minimum Eligible Age

6 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhu Xiaofan

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhu Xiaofan

Role: STUDY_CHAIR

Institute of Hematology & Blood Disease Hospital

Locations

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InstituteHBDH

Tianjin, Tianjin Municipality, China

Site Status

Countries

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China

Other Identifiers

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RE2016001-EC-1

Identifier Type: -

Identifier Source: org_study_id

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