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

Acute Myeloid Leukemia, Pediatric Clinical Trial

Official title:

Efficacy Analysis of Comparison of CAMS-2005 Trial and CAMS-2009 Trial for Pediatric Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03165851
• Other study ID #: RE2016001-EC-1
• Status: Completed
• Phase: N/A
• First received: May 16, 2017
• Last updated: May 24, 2017
• Start date: April 10, 2005
• Est. completion date: December 31, 2015

Study information

• Verified date: May 2017
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The outcomes of CAMS-2009 trial were retrospectively analyzed, and compared to the CAMS-2005 trial.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: December 31, 2015
• Est. primary completion date: December 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 16 Years

Eligibility

Inclusion Criteria:

• newly diagnosed AML

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia, Pediatric
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Other:
• Risk-stratified therapy
Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.

Locations

Country	Name	City	State
China	InstituteHBDH	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)	overall survival	From date of diagnosed until the date of death from any cause, assessed up to 60 months
Primary	event-free survival (EFS)	event-free survival	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
Primary	complete remission (CR)	fewer than 5% blast cells in the bone marrow aspirate and the absence of extramedullary involvement (EMI)	through study completion, an average of 1 year