Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Whether Idarubicin can overcomes multidrug resistant 1 induced chemoresistance with higher induction remission rate than daunorubicin in de novo acute myeloid leukemia patients.Whether induction therapy with IA regimen has a higher remission quality with AML patients than that of DA regimen in high MDR1 expression AML patients.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nanfang Hospital of Southern Medical University
• Collaborator: Pfizer
• Treatments: Daunorubicin; Idarubicin

Criteria

Inclusion Criteria:

• • Diagnosis of AML (WHO classification definition of >/= 20% blasts).

• Patients aged 16 to 60 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusion, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed.

• The relative expression level of MDR1 mRNA (MDR1/GAPDH ratio using the quantitative real-time PCR) in pre-treated bone marrow samples should over 0.016 (cut-off point from our results of preliminary experiment data )

• ECOG PS of 0, 1, 2 at screening.

• Serum biochemical values with the following limits: - creatininetotal bilirubintransaminases (SG PT)
• Ability to understand and provide signed informed consent.

Exclusion Criteria:

• • Subjects with Acute Promyelocytic Leukemia (APL).

• Presence of active systemic infection.

• Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.

• Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, IUD, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.