Acute Myeloid Leukemia, PediatricNCT03165851
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 of Acute Myeloid Leukemia, Pediatric, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Acute Myeloid Leukemia, Pediatric
- What is being tested?
- Risk-stratified therapy
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2005to 31 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients admitted to the Department of Pediatrics, Institute of Hematology \& Blood Disease Hospital.
Who may be able to join
- newly diagnosed AML
Who cannot join
- children with Down's syndrome and acute promyelocytic leukemia (APL)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
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.
- Conditions
- Acute Myeloid Leukemia, Pediatric
- Being tested
- Risk-stratified therapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk-stratified therapyOther
Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Risk-stratified therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival (OS)
overall survival
Measured: From date of diagnosed until the date of death from any cause, assessed up to 60 months
event-free survival (EFS)
event-free survival
Measured: 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
complete remission (CR)
fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start10 Apr 2005
- Primary completion31 Dec 2012
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia, PediatricStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhu Xiaofan, Study chair, Institute of Hematology & Blood Disease Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165851
- Sponsor's protocol ID
- RE2016001
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The outcomes of CAMS（Chinese Academy of Medical Sciences）-2009 trial are retrospectively analyzed, and compared to the CAMS-2005 trial.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT03165851
- Acronym / sponsor ID
- RE2016001
- Conditions
- Acute Myeloid Leukemia, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 10 Apr 2005 (actual)
- Primary completion
- 31 Dec 2012 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Risk-stratified therapyThe 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. |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients admitted to the Department of Pediatrics, Institute of Hematology \& Blood Disease Hospital.
Key inclusion criteria (1 listed)
- newly diagnosed AML
Key exclusion criteria (1 listed)
- children with Down's syndrome and acute promyelocytic leukemia (APL)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk-stratified therapyDose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy. | Other | CAMS-2009 trial |
Primary outcome
overall survival (OS)
Time frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months
overall survival
event-free survival (EFS)
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
event-free survival
complete remission (CR)
Time frame: through study completion, an average of 1 year
fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided. The outcomes of CAMS（Chinese Academy of Medical Sciences）-2009 trial are retrospectively analyzed, and compared to the CAMS-2005 trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhu Xiaofan study chair
Institute of Hematology & Blood Disease Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia, Pediatric, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (OS) (time frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.