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

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ClinicalTrials.gov Identifier: NCT03165851
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Zhu Xiaofan, Institute of Hematology & Blood Diseases Hospital

Brief 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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia, Pediatric Other: Risk-stratified therapy

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Study Type : Observational
Actual Enrollment : 320 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
Actual Study Start Date : April 10, 2005
Actual Primary Completion Date : December 31, 2012
Actual Study Completion Date : December 31, 2015


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




Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: From date of diagnosed until the date of death from any cause, assessed up to 60 months ]
    overall survival

  2. 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

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • newly diagnosed AML

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165851


Locations
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China, Tianjin
InstituteHBDH
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Study Chair: Zhu Xiaofan Institute of Hematology & Blood Disease Hospital
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Responsible Party: Zhu Xiaofan, Director, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT03165851    
Other Study ID Numbers: RE2016001-EC-1
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms