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

Not Applicable

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Daunorubicin; Drug: Cytarabine

• Registration Number: NCT02432872
• Lead Sponsor: Jianxiang Wang

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.

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-01
• Study First Posted: 2015-05-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07
• Primary Completion: 2018-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
escalated daunorubicin	Daunorubicin	Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
escalated daunorubicin	Cytarabine	Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
standard daunorubicin	Daunorubicin	Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
standard daunorubicin	Cytarabine	Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.
medium dosage cytarabine	Cytarabine	1g/m2 q12h for 3 days as consolidation therapy.
standard dosage cytarabine	Cytarabine	100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.

Primary Outcome Measures

Name	Time	Method
overall survival	3 years

Secondary Outcome Measures

Name	Time	Method
complete remission rate	2 months
relapse free survival	3 years
complete remission rate in different risk group	2 month
treatment-related mortality	2 months

Trial Locations

Locations (1)

Treatment and Diagnosis Center of Leukemia; 🇨🇳 Tianjin, Tianjin, China