We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML) (AIvsAD)

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: NCT01145846
Recruitment Status : Unknown
Verified June 2010 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
First Posted : June 17, 2010
Last Update Posted : June 17, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this non-inferiority study is to compare the effectiveness of two induction chemotherapy regimens (cytarabine plus idarubicin [AI] versus cytarabine plus high-dose daunorubicin [AD]) in AML. The effectiveness will be evaluated in terms of complete remission (CR) rate.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia Drug: Cytarabine plus Daunorubicin [Arm II (AD regimen)] Phase 3

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Idarubicin and High-dose Daunorubicin in Combination With Cytarabine in the Induction Chemotherapy for Acute Myeloid Leukemia
Study Start Date : May 2010
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : April 2014


Arms and Interventions

Arm Intervention/treatment
Experimental: Arm I (AI regimen)
Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Idarubicin 12 mg/m2/day iv daily for 3 days (D 1-3)
Drug: Cytarabine plus Daunorubicin [Arm II (AD regimen)]
Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3)
Other Name: Cytarabine /Idarubicin


Outcome Measures

Primary Outcome Measures :
  1. Complete remission rate [ Time Frame: five years ]
    A complete remission will be defined as blasts of 5% or less in a normocellular bone marrow with neutrophils of 1,000/mcL or more and platelets of 100,000/mcL or more in the peripheral blood, the disappearance of all blasts in the peripheral blood, and no evidence of extramedullary leukemic cell infiltration


Secondary Outcome Measures :
  1. Duration of CR, relapse-free survival(RFS),event-free survival(EFS),Overall survival(OS) [ Time Frame: Five years ]
    • This study will evaluate the impacts of induction chemotherapy regimen on duration of CR, relapse-free survival (RFS), event-free survival (EFS), and overall survival (OS).
    • This study will also evaluate the clinical significance of genetic polymorphisms of drug-metabolizing enzymes and mutations of leukemia-related genes.


Eligibility Criteria

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:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with previously-untreated acute myeloid leukemia (20% or more of blasts in bone marrow and/or blood; M6 subtype may have less than 20% of blasts.). Therapy-related leukemia or leukemia after myelodysplastic syndrome will be included.
  • 15 years old or older, but 65 years or younger
  • Adequate performance status (Karnofsky score of 50 or more)
  • Adequate hepatic and renal function (AST, ALT, bilirubin and creatinine < 2.5 x upper normal limit). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
  • Adequate cardiac function (left ventricular ejection fraction of 45% or more on heart scan or echocardiogram)
  • Signed and dated informed consent must be obtained

Exclusion Criteria:

  • Patients with acute promyelocytic leukemia or bcr-abl gene rearrangement
  • Patients with CNS leukemia
  • Patients with primary granulocytic sarcoma without bone marrow involvement
  • Prior chemotherapy for leukemia or anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
  • Presence of significant active infection
  • Presence of uncontrolled bleeding
  • Significant cardiovascular disease including myocardial infarction within previous 6 months
  • Any coexisting major illness or organ failure
  • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
  • Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
  • Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Contacts and Locations

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): NCT01145846


Contacts
Contact: Je-Hwan Lee, professor 82-2-3010-3218 jhlee3@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-gu, Korea, Republic of, 138-736
Contact: Ye Eun Jang, nurse    82-2-3010-6378    redpin75@paran.com   
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Je Hwan Lee, Professor Asan Medical Center
More Information

Additional Information:
Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01145846     History of Changes
Other Study ID Numbers: C-022
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: June 17, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Daunorubicin
Idarubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors