PHASE I CLINICAL TRIAL OF DOMESTIC MAMSA IN PATIENTS WITH ACUTE LEUKEMIAS

The phase I clinical trial of domestic m-AMSA in 9 patients with acute leukemia showed that the size of hepatosplenomegaly , bone pains, and the marrow blasts could be reduced by using the 3dosages of 50, 70 and 90mg/m2/d of m-AMSA for 5 days. One of the 3 patients treated with 90mg/m 2 /d regimen achieved bone marrow complete remission (CR). The common side effects and toxicities were alopecia, anorexia, nousea and vomiting, mucositis, and myelosuppression. The patient who received 90mg/m2/d regimen and achieved bone marrow CR presented severe gastrointestinal ulcer, bloody stool, myelosuppression, secondary pneumonitis and septicemia. The pharmacokinetic characteristics of the m-AMSA and its correlations with the toxicities were analyzed. Key words: Amsacrine (m-AMSA); acute leukemia; phase I clinical trial; pharmacokinetics