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CompletedNCT03165851Updated Feb 11, 2026

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

An observational study in Acute Myeloid Leukemia, Pediatric, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Completed at 1 site in China. Open to participants aged 6 Months to 16 Years. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
320
Ages
6 Months to 16 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Acute Myeloid Leukemia, Pediatric
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In context

Leukemia, Myeloid, Acute

2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.

This study's enrollment of 320 is above the median of 120 across 317 observational studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 398 studies on the registry; 293 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the Department of Pediatrics, Institute of Hematology \& Blood Disease Hospital.

Inclusion criteria

  • newly diagnosed AML

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
320 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

  • 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.

    Other: Risk-stratified therapy

Interventions

  • OtherRisk-stratified therapy

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

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What researchers measure

Primary outcomes

  1. overall survival (OS)

    overall survival

    Time frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months

  2. event-free survival (EFS)

    event-free survival

    Time frame: 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

  3. complete remission (CR)

    fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)

    Time frame: through study completion, an average of 1 year

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Study locations

1 site
  • InstituteHBDH
    Tianjin, Tianjin Municipality 300020, China
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References and documents

Individual participant data

Plan to share: Undecided — The outcomes of CAMS(Chinese Academy of Medical Sciences)-2009 trial are retrospectively analyzed, and compared to the CAMS-2005 trial.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03165851
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Responsible party
Sponsor
First posted
May 24, 2017
Start date
Apr 10, 2005
Primary completion
Dec 31, 2012
Completion
Dec 31, 2015
Last update
Feb 11, 2026

Study contacts

Zhu Xiaofan
study chair · Institute of Hematology & Blood Disease Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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