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

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Daunorubicin
Cytarabine
Sponsored by
Jianxiang Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

55 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Treatment and Diagnosis Center of LeukemiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

escalated daunorubicin

standard daunorubicin

medium dosage cytarabine

standard dosage cytarabine

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

complete remission rate
relapse free survival
complete remission rate in different risk group
treatment-related mortality

Full Information

First Posted
April 29, 2015
Last Updated
October 6, 2016
Sponsor
Jianxiang Wang
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1. Study Identification

Unique Protocol Identification Number
NCT02432872
Brief Title
Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years
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 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
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.
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.

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
escalated daunorubicin
Arm Type
Experimental
Arm Description
Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
Arm Title
standard daunorubicin
Arm Type
Active Comparator
Arm Description
Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
Arm Title
medium dosage cytarabine
Arm Type
Experimental
Arm Description
1g/m2 q12h for 3 days as consolidation therapy.
Arm Title
standard dosage cytarabine
Arm Type
Active Comparator
Arm Description
100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.
Intervention Type
Drug
Intervention Name(s)
Daunorubicin
Other Intervention Name(s)
daunomycin
Intervention Description
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
Intervention Type
Drug
Intervention Name(s)
Cytarabine
Other Intervention Name(s)
cytosine arabinoside
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
3 years
Secondary Outcome Measure Information:
Title
complete remission rate
Time Frame
2 months
Title
relapse free survival
Time Frame
3 years
Title
complete remission rate in different risk group
Time Frame
2 month
Title
treatment-related mortality
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlin - Zhou, MD
Phone
+8613820429085
Email
zcl7317@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianxiang Wang, MD
Organizational Affiliation
ChineseAMS
Official's Role
Principal Investigator
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 Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years

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