Status:
UNKNOWN
Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Collaborating Sponsors:
Pfizer
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
14-60 years
Brief 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 thera...
Detailed Description
The long-term survival rate of acute myeloid leukemia (AML) has been significantly prolonged due to the improvement of chemotherapeutic protocols and hemopoietic stem cell transplantation. However, ab...
Eligibility Criteria
Inclusion
- • 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: - creatinine \</= 2.0 mg/dl - total bilirubin \</= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) \</= 3x ULN
- Ability to understand and provide signed informed consent.
Exclusion
- • 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01889407
Start Date
August 1 2013
End Date
July 1 2016
Last Update
April 21 2015
Active Locations (1)
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1
Bing Xu
Guangzhou, Guangdong, China, 510515