A phase II study of high dose ARA-C and mitoxantrone for treatment of relapsed or refractory adult acute lymphoblastic leukemia

Purpose: The Southwest Oncology Group performed a Phase II study to investi gate the effectiveness of an induction regimen of high dose cytosine arabin oside (ara-C) with high dose mitoxantrone for treatment of relapsed or refr actory adult acute lymphoblastic leukemia (ALL). Patients and methods: Pati ents at least 16-years-old with ALL that was in relapse after, or was refra ctory to, standard induction therapy including at least vincristine and pre dnisone were eligible, as long as they had no prior treatment with high dos e ara-C. The induction regimen included high dose ara-C (3 g/m(2) by 3-h IV days 1-5) and mitoxantrone (80 mg/m(2) by 15-30 min IV 12-20 h after the f irst dose of ara-C). The study design called for a maximum of 55 patients, with early termination if less than nine of the first 30 achieved complete remission. Results: Thirty-three patients entered the study, and 31 were in cluded in the analysis. All 31 completed one course of induction therapy. F our patients died of infection and a fifth of cardiomyopathy with possible sepsis. Seven patients achieved complete remission (23%; 95% confidence int erval 10-41%). One of the seven received syngeneic bone marrow transplantat ion while in remission, and the other six all relapsed within 10 months. Al l 31 patients died within 25 months after entering the study. Conclusions: The regimen of high dose ara-C and mitoxantrone was found to be insufficien tly effective to warrant further investigation. (C) 2000 Elsevier Science L td. All rights reserved.