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

NCT03165851 | Completed

• 1 other identifier: RE2016001
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia, Pediatric

Outcome Measures

Primary Outcomes (3)

• overall survival (OS)

  overall survival

  From date of diagnosed until the date of death from any cause, assessed up to 60 months

• 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

• 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

Study Arms (2)

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

Interventions

Risk-stratified therapy OTHER

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

CAMS-2009 trial

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Department of Pediatrics, Institute of Hematology \& Blood Disease Hospital.

You may qualify if:

• newly diagnosed AML

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

InstituteHBDH

Tianjin, Tianjin Municipality, 300020, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhu Xiaofan

  Institute of Hematology & Blood Disease Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 24, 2017
• Study Start: April 10, 2005
• Primary Completion: December 31, 2012
• Study Completion: December 31, 2015
• Last Updated: February 11, 2026

Record last verified: 2017-05

Locations

CN (1)