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- Title
Phase I/II Trial of Nanomolecular Liposomal Annamycin in Adult Patients With Relapsed/ Refractory Acute Lymphoblastic Leukemia.
- Authors
Wetzler, Meir; Thomas, Debora A.; Wang, Eunice S.; Shepard, Robert; Ford, Laurie A.; Heffner, Thompson L.; Parekh, Samir; Andreeff, Michael; O'Brien, Susan; Kantarjian, Hagop M.
- Abstract
A phase I/II trial of nanomolecular liposomal annamycin in relapsed/refractory acute lymphoblastic leukemia (ALL) was well-tolerated and has shown clinical activity as a single agent. Background: Treatment options for relapsed/refractory ALL in adult patients remain challenging. Annamycin is a highly lipophilic form of the anthracycline doxorubicin with the ability to bypass multidrug resistance mechanisms of cellular drug resistance. Patients and Methods: We performed a phase I/II multicenter, 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/d for 3 days. Other than tumor lysis syndrome, there were 3 grade 3 mucositis which comprised the MTD determination. There was also 1 case each of grade 3 diarrhea, typhlitis, and nausea. After determining the MTD, a 10-patient phase IIA trial was conducted. Eight of the patients completed 1 cycle of the 3 days of treatment at the MTD. Of these, 5 (62%) had an efficacy signal with complete clearing of circulating peripheral blasts. Three of these subjects also cleared bone marrow blasts with 1 subsequently proceeding onto successful stem cell transplantation. Conclusion: Single-agent nanomolecular liposomal annamycin appears to be well tolerated, and shows evidence of clinical activity as a single agent in refractory adult ALL.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2013, Vol 13, Issue 4, p430
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/j.clml.2013.03.015