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Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years

Sponsor
Jianxiang Wang (Other)
Overall Status
Unknown status
CT.gov ID
NCT02432872
Collaborator
(none)
300
Enrollment
1
Location
4
Arms
73
Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether the escalation dosage of Daunorubicin and cytarabine is effective and safety in the treatment of older adult Chinese acute myeloid leukemia（AML） patients aged 55 to 65 years.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

the DA 3+7 regimen is the standard therapy in the AML treatment.Escalated dosage of daunorubicin in induction therapy is reported effective and result in a more rapid response and a higher response rate than does the conventional dose, without additional toxic effects in elderly AML patients between 60 to 65 years.Higher Overall survival rate and Event-free survival rate was obtained in escalated group compared with conventional dose. We are wondering if Chinese older AML patients can benefit from this escalated induction regimen.

High dose cytarabine in AML consolidation is reported improving the survival of elderly AML patients than the conventional dose，but it is not determined in Chinese older adult AML patients.

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，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 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: escalated daunorubicin

Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.

Drug: Daunorubicin
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
Other Names:
  • daunomycin

    • Drug: Cytarabine
    medium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy.
    Other Names:
  • cytosine arabinoside

    		•
    Active Comparator: standard daunorubicin

    Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.

    Drug: Daunorubicin
    defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
    Other Names:
  • daunomycin

    • Drug: Cytarabine
    medium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy.
    Other Names:
  • cytosine arabinoside

    		•
    Experimental: medium dosage cytarabine

    1g/m2 q12h for 3 days as consolidation therapy.

    Drug: Cytarabine
    medium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy.
    Other Names:
  • cytosine arabinoside

    		•
    Active Comparator: standard dosage cytarabine

    100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.

    Drug: Cytarabine
    medium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy.
    Other Names:
  • cytosine arabinoside

    		•

    Outcome Measures

    Primary Outcome Measures

    1. overall survival [3 years]

    Secondary Outcome Measures

    1. complete remission rate [2 months]

    2. relapse free survival [3 years]

    3. complete remission rate in different risk group [2 month]

    4. treatment-related mortality [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • primary AML（except APL patients）;

    • ECOG PS:0-2

    Exclusion Criteria:

    • AML patient who has already received induction treatment, no matter what the outcome is;

    • Treatment-related AML;

    • Active cancer patients who's condition need to be treated;

    • The one with serious infectious diseases（eg.uncontrolled 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

    • Principal Investigator: Jianxiang Wang, MD, Chinese Academy of Medical Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jianxiang Wang, vise-president, Chinese Academy of Medical Sciences
    ClinicalTrials.gov Identifier:
    NCT02432872
    Other Study ID Numbers:
    • IHBDH-IIT2015002
    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
    Daunorubicin

    Study Results

    No Results Posted as of Oct 7, 2016