- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165851
Efficacy Analysis of Comparison of CAMS(Chinese Academy of Medical Sciences)-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
May 24, 2017 updated by: Zhu Xiaofan, Institute of Hematology & Blood Diseases Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
320
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tianjin
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Tianjin, Tianjin, China, 300020
- InstituteHBDH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the Department of Pediatrics, Institute of Hematology & Blood Disease Hospital.
Description
Inclusion Criteria:
- newly diagnosed AML
Exclusion Criteria:
- children with Down's syndrome and acute promyelocytic leukemia (APL)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
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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.
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Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
overall survival (OS)
Time Frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months
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overall survival
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From date of diagnosed until the date of death from any cause, assessed up to 60 months
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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
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event-free survival
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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
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complete remission (CR)
Time Frame: through study completion, an average of 1 year
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fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)
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through study completion, an average of 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Zhu Xiaofan, Institute of Hematology & Blood Disease Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 10, 2005
Primary Completion (Actual)
December 31, 2012
Study Completion (Actual)
December 31, 2015
Study Registration Dates
First Submitted
May 16, 2017
First Submitted That Met QC Criteria
May 22, 2017
First Posted (Actual)
May 24, 2017
Study Record Updates
Last Update Posted (Actual)
May 30, 2017
Last Update Submitted That Met QC Criteria
May 24, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RE2016001-EC-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
The outcomes of CAMS(Chinese Academy of Medical Sciences)-2009 trial are retrospectively analyzed, and compared to the CAMS-2005 trial.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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