Idarubicin Overcomes MDR1 Induced Chemoresistance With Higher Induction Remission Rate and Quality Than Daunorubicin in Acute Myeloid Leukemia Patients
Idarubicin Overcomes Multidrug Resistant-1(MDR1) Induced Chemoresistance With Higher Induction Remission Rate and Remission Quality Than Daunorubicin in de Novo Acute Myeloid Leukemia Patients
1 other identifier
observational
94
1 country
1
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 therapy with IA regimen has a higher remission quality with AML patients than that of DA regimen in high MDR1 expression AML patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
June 28, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedApril 21, 2015
July 1, 2013
2.9 years
June 26, 2013
April 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete remission rate
3 year
Secondary Outcomes (1)
WT1 and MDR1 expression level change after 2 courses of chemotherapy with IA regimen or DA regimen in high-MDR1 expression AML patients.
3 years
Other Outcomes (1)
Identify 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.
3 years
Study Arms (2)
IA regimen
IA regimen: Patients receive idarubicin (8mg/m2.d) iv drip on days 1-3 and cytarabine (100-200mg/ m2.d) iv drip on days 1-7.
DA regimen
Patients receive daunomycin (45mg/ m2.d) iv drip on days 1-3 and cytarabine (100-200mg/ m2.d) iv drip on days 1-7.
Interventions
Eligibility Criteria
• 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
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nanfang Hospital, Southern Medical Universitylead
- Pfizercollaborator
Study Sites (1)
Bing Xu
Guangzhou, Guangdong, 510515, China
Related Publications (1)
Shi P, Zha J, Guo X, Chen F, Fan Z, Huang F, Meng F, Liu X, Feng R, Xu B. Idarubicin is superior to daunorubicin in remission induction of de novo acute myeloid leukemia patients with high MDR1 expression. Pharmacogenomics. 2013 Jan;14(1):17-23. doi: 10.2217/pgs.12.182.
PMID: 23252945BACKGROUND
Related Links
Biospecimen
Bone marrow
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bing Xu, M.D
Department of Hematology, Nanfang Hospital, The Southern Medical University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
June 28, 2013
Study Start
August 1, 2013
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
April 21, 2015
Record last verified: 2013-07