A phase I and II study of m-AMSA in acute leukaemia.

Thirty-two patients with relapsed or resistant acute leukaemia were treated with m-AMSA at doses ranging from 50-150 mg/m2 daily for 5 days. Complete remission was achieved in three of 18 patients with acute myeloblastic leukaemia, two of nine patients with acute lymphoblastic leukaemia, and none of five patients with blastic crisis of chronic myeloid leukaemia. The complete remissions all occurred at doses of 100 mg/m2 per day or above. Haematological toxicity occurred in all patients and was dose-related. Nausea and vomiting were mild and easily controlled. Alopecia was uncommon at the lower doses but occurred in all patients receiving the higher doses. Stomatitis was noted in only 8% of courses at 50 mg/m2 but was seen in 50% of courses at 150 mg/m2. Mild and transient elevations of liver enzymes were common. m-AMSA is an active drug in acute leukaemia, with acceptable toxicity. Its place in combination chemotherapy is now being explored.