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

Jianxiang Wang

Status: Unknown

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Daunorubicin; Drug: Cytarabine

Study type: Interventional

Funder types: Other

Identifiers

NCT02432872

IHBDH-IIT2015002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

escalated daunorubicin

Experimental group

Description:

Daumorubicin 60mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.

Treatment:

Drug: Cytarabine

Drug: Daunorubicin

standard daunorubicin

Active Comparator group

Description:

Daunorubicin 45mg/m2 per day for 3 days combined with Cytaruabine 100mg/m2 per day for 7 days.

Treatment:

Drug: Cytarabine

Drug: Daunorubicin

medium dosage cytarabine

Experimental group

Description:

1g/m2 q12h for 3 days as consolidation therapy.

Treatment:

Drug: Cytarabine

standard dosage cytarabine

Active Comparator group

Description:

100mg/m2 cytarabine for 6 days combined with aclacinomycin 20mg per day for 6 days as consolidation therapy.

Treatment:

Drug: Cytarabine