Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years
A Multicenter，Open-label，Radonmized Study on the Treatment of Older Adult Acute Myeloid Leukemia Patients Aged 55 to 65 Years Old
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedOctober 7, 2016
May 1, 2016
3.1 years
April 29, 2015
October 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
overall survival
3 years
Secondary Outcomes (4)
complete remission rate
2 months
relapse free survival
3 years
complete remission rate in different risk group
2 month
treatment-related mortality
2 months
Study Arms (4)
escalated daunorubicin
EXPERIMENTALDaumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
standard daunorubicin
ACTIVE COMPARATORDaunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
medium dosage cytarabine
EXPERIMENTAL1g/m2 q12h for 3 days as consolidation therapy.
standard dosage cytarabine
ACTIVE COMPARATOR100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.
Interventions
defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
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.
Eligibility Criteria
You may qualify if:
- primary AML（except APL patients）;
- ECOG PS:0-2
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jianxiang Wanglead
Study Sites (1)
Treatment and Diagnosis Center of Leukemia
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianxiang Wang, MD
ChineseAMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- UNKNOWN
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- vise-president
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 4, 2015
Study Start
April 1, 2015
Primary Completion
May 1, 2018
Study Completion
May 1, 2021
Last Updated
October 7, 2016
Record last verified: 2016-05