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

Sponsor
Jianxiang Wang (Other)
Overall Status
Unknown status
CT.gov ID
NCT02432911
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
73
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)
  • Drug: low dose cytarabine
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
May 1, 2018
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAG regimen

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.

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.
Active Comparator: Low dose cytarabine

cytarabine 20mg bid for 10 days.

Drug: low dose cytarabine
cytarabine 20mg bid for 10 days.
Other Names:
  • cytarabine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [3 years]

    Secondary Outcome Measures

    1. complete remission rate [4 months]

    2. relapse free survival [3 years]

    3. treatment-related mortality [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Treatment and Diagnosis Center of Leukemia Tianjin Tianjin China 300020

    Sponsors and Collaborators

    • Jianxiang Wang

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianxiang Wang, vice-president, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02432911
    Other Study ID Numbers:
    • IHBDH-IIT2015003
    First Posted:
    May 4, 2015
    Last Update Posted:
    Oct 7, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Cytarabine
    Aclacinomycins

    Study Results

    No Results Posted as of Oct 7, 2016