Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old

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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This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.

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Detailed Description

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Low dose cytarabine remains to be the choice of standard for elderly AML patients who are unfit or unwilling to receive intensive treatment. CAG regimen, which is a combination of aclacinomycin，low dose cytarabine±G-CSF is used often in elderly AML patients in China. It is proved effective and safety in some pilot studies，while there is no prospective，randomized study yet.

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

Study Groups

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CAG regimen

Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.

Group Type EXPERIMENTAL

CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)

Intervention Type DRUG

Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.

Low dose cytarabine

cytarabine 20mg bid for 10 days.

Group Type ACTIVE_COMPARATOR

low dose cytarabine

Intervention Type DRUG

cytarabine 20mg bid for 10 days.

Interventions

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CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)

Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.

Intervention Type DRUG

low dose cytarabine

cytarabine 20mg bid for 10 days.

Intervention Type DRUG

Other Intervention Names

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cytarabine

Eligibility Criteria

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Inclusion Criteria

* Acute myeloid leukemia except APL
* ECOG PS：0-3
* Unfit or unwilling to receive intensive therapy

Exclusion Criteria

* The one who has already received induction therapy no matter what the outcome is.
* Active cancer patients who are needed to receive treatment;
* Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）；
* Active heart disease

Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No