Back to resultsTreatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
Primary Purpose
Acute Myeloid Leukemia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)
low dose cytarabine
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
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
Sites / Locations
- Treatment and Diagnosis Center of LeukemiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CAG regimen
Low dose cytarabine
Arm Description
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.
cytarabine 20mg bid for 10 days.
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
complete remission rate
relapse free survival
treatment-related mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02432911
Brief Title
Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
Official Title
A Multicenter，Open-label，Randomized Study on the Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jianxiang Wang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAG regimen
Arm Type
Experimental
Arm Description
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.
Arm Title
Low dose cytarabine
Arm Type
Active Comparator
Arm Description
cytarabine 20mg bid for 10 days.
Intervention Type
Drug
Intervention Name(s)
CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
low dose cytarabine
Other Intervention Name(s)
cytarabine
Intervention Description
cytarabine 20mg bid for 10 days.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
complete remission rate
Time Frame
4 months
Title
relapse free survival
Time Frame
3 years
Title
treatment-related mortality
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxiang Wang, MD
Phone
+862223909120
Email
wangjx@cams.ac.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlin Zhou, MD
Phone
+8613820429085
Email
zhouchunlin@cams.ac.cn
Facility Information:
Facility Name
Treatment and Diagnosis Center of Leukemia
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxiang Wang, MD
Phone
+862223909120
Email
wangjx@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Chunlin Zhou, MD
Phone
+8613820429085
Email
zcl7317@sina.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old
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