ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 29 of 253 for:    IDARUBICIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01889407
Recruitment Status : Unknown
Verified July 2013 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : June 28, 2013
Last Update Posted : April 21, 2015
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Drug: Idarubicin

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 94 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: 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
Study Start Date : August 2013
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : July 2016


Group/Cohort Intervention/treatment
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.
Drug: Idarubicin
8 mg/m2, iv drip on days 1-3

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.



Primary Outcome Measures :
  1. complete remission rate [ Time Frame: 3 year ]

Secondary Outcome Measures :
  1. WT1 and MDR1 expression level change after 2 courses of chemotherapy with IA regimen or DA regimen in high-MDR1 expression AML patients. [ Time Frame: 3 years ]

Other Outcome Measures:
  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. [ Time Frame: 3 years ]

Biospecimen Retention:   Samples With DNA
Bone marrow


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   14 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
• 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
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: - 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889407


Contacts
Contact: Bing Xu, M.D 13189096353 ext 510515 xubingzhangjian@126.com
Contact: Xutao Guo, M.D 13802426709 ext 510515 gxt827@126.com

Locations
China, Guangdong
Bing Xu Recruiting
GuangZhou, Guangdong, China, 510515
Contact: Bing Xu, M.D    13189096353    xubingzhangjian@126.com   
Contact: Xutao Guo, M.D    13802426709    gxt827@126.com   
Principal Investigator: Bing Xu, M.D         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Pfizer
Investigators
Study Chair: Bing Xu, M.D Department of Hematology, Nanfang Hospital, The Southern Medical University

Additional Information:
Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01889407     History of Changes
Other Study ID Numbers: IDA20130517
IDA20130517 ( Other Identifier: Company of Pfizer )
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: July 2013

Keywords provided by Nanfang Hospital of Southern Medical University:
Acute Myeloid Leukemia

Additional relevant MeSH terms:
Idarubicin
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Daunorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action