Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

Acute Myeloid Leukemia Clinical Trial

Official title:

A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02432911
• Other study ID #: IHBDH-IIT2015003
• Status: Recruiting
• Phase: N/A
• First received: April 29, 2015
• Last updated: October 6, 2016
• Start date: April 2015
• Est. completion date: May 2021

Study information

• Verified date: May 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Jianxiang Wang, MD
• Phone: +862223909120
• Email: wangjx[@]cams.ac.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.

Description:

Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2021
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 75 Years

Eligibility

Inclusion Criteria:

• Acute myeloid leukemia except APL

• ECOG PS:0-3

• Unfit or unwilling to receive intensive therapy

Exclusion Criteria:

• The one who has already received induction therapy no matter what the outcome is.

• Active cancer patients who are needed to receive treatment;

• Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis);

• Active heart disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)
Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.
• low dose cytarabine
cytarabine 20mg bid for 10 days.

Locations

Country	Name	City	State
China	Treatment and Diagnosis Center of Leukemia	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jianxiang Wang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 years	No
Secondary	complete remission rate		4 months	No
Secondary	relapse free survival		3 years	No
Secondary	treatment-related mortality		2 months	Yes