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

October 6, 2016 updated by: Jianxiang Wang

A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300020
        • Recruiting
        • Treatment and Diagnosis Center of Leukemia
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
relapse free survival
Time Frame: 3 years
3 years
treatment-related mortality
Time Frame: 2 months
2 months
complete remission rate
Time Frame: 2 months
2 months
complete remission rate in different risk group
Time Frame: 2 month
2 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jianxiang Wang

Investigators

  • Principal Investigator: Jianxiang Wang, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 1, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHBDH-IIT2015002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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