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Author Notes:

Meir Wetzler, MD, Leukemia Section, Department of Medicine, Roswell Park Cancer Institute, Elm and Carlton Streets, Buffalo, NY 14263 USA; Tel: 716-845-8447, Fax: 716-845-2343, meir.wetzler@roswellpark.org.

Dr. Wetzler was the Principal Investigator at Roswell Park Cancer Institute, contributed to patient care, oversaw data collection and wrote the manuscript.

Dr. Thomas contributed to the care of the patients; Dr. Wang contributed to the care of the patients; Dr. Shepard was the Principal Investigator at Callisto; Mrs. Ford assisted in data collection and constructed the database; Dr. Heffner was the Principal Investigator at the Winship Cancer Institute of Emory University and contributed to the care of the patients; Dr. Parekh was the Principal Investigator at Albert Einstein College of Medicine and contributed to the care of the patients; Dr. Andreef contributed to the care of the patients; Dr. O’Brien contributed to the care of the patients; Dr. Kantarjian was the Principal Investigator at M. D. Anderson Cancer Center and contributed to the care of the patients.

All co-authors read the final version of the manuscript.


Research Funding:

Supported partially by grants from the National Cancer Institute Grant CA16056 (MW, ESW, LAF); the Szefel Foundation; Roswell Park Cancer Institute (ESW); the Nancy C. Cully Endowment for Leukemia Research (MW); and the Leonard S. LuVullo Endowment for Leukemia Research (MW).

All authors also received funding from Callisto Pharmaceuticals (New York, NY).


  • Science & Technology
  • Life Sciences & Biomedicine
  • Oncology
  • Hematology
  • Clinical trial
  • Refractory disease
  • Relapsed disease

Phase I/II Trial of Nanomolecular Liposomal Annamycin in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia


Journal Title:

Clinical Lymphoma, Myeloma and Leukemia


Volume 13, Number 4


, Pages 430-434

Type of Work:

Article | Post-print: After Peer Review


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.

Copyright information:

© 2013 Elsevier Inc. All rights reserved.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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