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

• Status: Unknown status
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cooperative Study Group A for Hematology
• Treatments: Cytarabine; Daunorubicin; Idarubicin

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)