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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Cooperative Study Group A for Hematology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT01145846
First received: May 19, 2010
Last updated: June 16, 2010
Last verified: June 2010
  Purpose

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 Intervention Phase
Acute Myelogenous Leukemia
Drug: Cytarabine plus Daunorubicin [Arm II (AD regimen)]
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • Complete remission rate [ Time Frame: five years ] [ Designated as safety issue: Yes ]
    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:
  • Duration of CR, relapse-free survival(RFS),event-free survival(EFS),Overall survival(OS) [ Time Frame: Five years ] [ Designated as safety issue: Yes ]
    • 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.


Estimated Enrollment: 316
Study Start Date: May 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01145846     History of Changes
Other Study ID Numbers: C-022
Study First Received: May 19, 2010
Last Updated: June 16, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014