A Prospective Randomized Comparison of HDAC vs AD in the Induction Chemothrapy for AML.

• Status: Enrolling by invitation
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus daunorubicin [HDAC] vs. cytarabine plus high-dose daunorubicin [AD]) in acute myeloid leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival (EFS, time from registration to induction failure, relapse, or death).

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

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Cytarabine; Daunorubicin

Criteria

Inclusion Criteria:

• Previously-untreated AML (≥ 20% blasts in bone marrow and/or peripheral blood)

• Age of 15 years or older, 60 years or younger

• Adequate performance status (Karnofsky score of 50 or more)

• Adequate hepatic and renal function (AST, ALT, and bilirubin < 2.5 x upper normal limit and creatinine < 2.0 mg/dL & creatinine clearance ≥ 50 mL/min). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.

• Adequate cardiac function (left ventricular ejection fraction ≥45% on heart scan or echocardiogram)

• Signed informed consent

Exclusion Criteria:

• Patients with history of chemotherapy for leukemia or cytarabine and anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.

• Patients with acute promyelocytic leukemia

• Patients with blast crisis of chronic myeloid leukemia

• Patients with central nervous system (CNS) leukemia or granulocytic sarcoma without bone marrow involvement

• Presence of uncontrolled and/or severe medical condition (infection, bleeding, cardiovascular disease including myocardial infarction within previous 6 months.)

• 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)