Status:
UNKNOWN
Idarubicin Versus High Dose Daunorubicin in Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
15-65 years
Phase:
PHASE3
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 \[AD\]...
Detailed Description
1. INDUCTION CHEMOTHERAPY * For patients randomized to receive Idarubicin (Arm I, AI regimen) will be given Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2014
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT01145846
Start Date
May 1 2010
End Date
April 1 2014
Last Update
June 17 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center
Seoul, Songpa-gu, South Korea, 138-736