PHASE-I-II TRIAL OF MITOXANTRONE IN ACUTE-LEUKEMIA

  • 1 January 1985
    • journal article
    • research article
    • Vol. 69  (1) , 61-64
Abstract
Mitoxantrone was evaluated in a multi-institution trial to define the effective dose for treating acute leukemia, to evaluate its toxicity, and to assess the induction rates for the different types of acute leukemia. Patients (57) were treated. Of the 24 patients receiving mitoxantrone (10 mg/m2 per day .times. 5), 1 of 9 with acute nonlymphoblastic leukemia (ANLL) in relapse, 1 of 5 with acute lymphoblastic leukemia in relapse, and 1 of 7 with blastic chronic myelogenous leukemia achieved remission. At a dose of 12 mg/m2 per day .times. 5, 7 of 16 patients with ANLL in relapse, 0 of 6 with acute lymphoblastic leukemia in relapse, and 1 of 5 with blastic chronic myelogenous leukemia achieved remission. At both dose levels, there was no response in patients who had failed to achieve a prior remission. Toxic effects included nausea/vomiting, stomatitis, and hepatic dysfunction. Nine of the 57 patients treated experienced cardiac events, but cardiac toxicity seemed clinically significant in only 3. Mitoxantrone, at a dose of 12 mg/m2 per day .times. 5, is effective therapy for ANLL. Trials combining mitoxantrone with other agents are needed.