Clinical trial · Observational
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
NCT01889407CI-TRIAL-00017598unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- IA regimen
- description
- 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.
- interventionNames
- Drug: Idarubicin
- label
- DA regimen
- description
- Patients receive daunomycin (45mg/ m2.d) iv drip on days 1-3 and cytarabine (100-200mg/ m2.d) iv drip on days 1-7.
Primary outcomes (1)
- measure
- complete remission rate
- timeFrame
- 3 year
Secondary outcomes (1)
- measure
- WT1 and MDR1 expression level change after 2 courses of chemotherapy with IA regimen or DA regimen in high-MDR1 expression AML patients.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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: - 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 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.
References
Publications (1)
- BACKGROUNDShi 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 23252945