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Background Treatment options for relapsed/refractory acute lymphoblastic leukemia (ALL) in adult patients remain challenging. Annamycin is a highly lipophilic form of the anthracycline doxorubicin with the ability to bypass multi-drug resistance mechanisms of cellular drug resistance. Patients and Methods We performed a phase I/II multi-center, open-label, study to determine the maximally tolerated dose (MTD) of nanomolecular liposomal annamycin in adult patients with refractory ALL. Results Thirty-one patients were enrolled; the MTD was determined to be 150 mg/m2/day for 3 days. Other than tumor lysis syndrome, there were three grade 3 mucositis which comprised the MTD determination. There was also one case each of grade 3 diarrhea, typhlitis and nausea. After determining the MTD, a 10-patient phase IIA was conducted. Eight of the patients completed one cycle of the three days of treatment at the MTD. Of these, five (62%) had an efficacy signal with complete clearing of circulating peripheral blasts. Three of these subjects also cleared bone marrow blasts with one subsequently proceeding onto successful stem cell transplantation. Conclusion Single agent nanomolecular liposomal annamycin appears to be well-tolerated and evidence of clinical activity as a single agent in refractory adult ALL.

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