Efficacy Analysis of Comparison of CAMS（Chinese Academy of Medical Sciences）-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03165851|
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 30, 2017
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia, Pediatric||Other: Risk-stratified therapy|
|Study Type :||Observational|
|Actual Enrollment :||320 participants|
|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|
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).
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.
- 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)
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
|Tianjin, Tianjin, China, 300020|
|Study Chair:||Zhu Xiaofan||Institute of Hematology & Blood Disease Hospital|