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

Jianxiang Wang

Status

Unknown

Conditions

Acute Myeloid Leukemia

Treatments

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

Drug: low dose cytarabine

Study type

Interventional

Funder types

Other

Identifiers

NCT02432911

IHBDH-IIT2015003

Details and patient eligibility

About

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.

Full description

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.

Enrollment

300 estimated patients

Sex

All

Ages

65 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 2 patient groups

CAG regimen

Experimental group

Description:

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.

Treatment:

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

Low dose cytarabine

Active Comparator group

Description:

cytarabine 20mg bid for 10 days.

Treatment:

Drug: low dose cytarabine