Preliminary Phase II Study of Aclacinomycin A in Patients With Adult Acute Leukemia

Seventeen patients with adult acute leukemia in relapse weretreated with aclacinomycin A in 5-day courses given at a doseof 90 to 210 mg/m²/5 days as a daily bolus injection. Completeremission was achieved in patients treated with 130 or moremg/m²/5 days. Three out of seven patients with acute nonlymphocyticleukemia achieved complete remission lasting 15 mo, 14+ mo,and 2 mo. Of seven patients with acute lymphocytic leukemia,one achieved complete remission which lasted more than 11 mo.One patient with refractory anemia with an excess of blast cellsalso achieved complete remission. Neutropenia and thrombocytopeniaoccurred in all patients. The dose-limiting factors were gastrointestinalsymptoms and stomatitis, the latter occurring in three of theseven patients who received 200–210 mg/m²/5 days. Hyperbilirubinemiaassociated with antibiotic therapy was seen in four patients.Since aclacinomycin A has significant activity in acute nonlymphocyticleukemia, consideration should be given to exploring its usein combination with other active drugs.