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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02432872

Enrollment

300

Registered

2015-05-04

Start date

2015-04-30

Completion date

2021-05-31

Last updated

2016-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

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.

Interventions

DRUGDaunorubicin

defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses

DRUGCytarabine

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
overall survival	3 years

Secondary

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

Countries

China

Contacts

Primary ContactChunlin - Zhou, MD

zcl7317@sina.com+8613820429085

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026