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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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

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Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

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.

Interventions

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Daunorubicin

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

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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daunomycin cytosine arabinoside

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No