NCT02432872

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Jianxiang Wang · Unknown
• Sex: All
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Daunorubicin	defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
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.

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-05-01
• Completion: 2021-05-01
• First posted: 2015-05-04
• Last updated: 2016-10-07

Locations

1 site across 1 country: China