Journal article
Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 monoclonal antibody HuM195
Leukemia, Vol.17(2), pp.314-318
2003
DOI: 10.1038/sj.leu.2402803
PMID: 12592328
Abstract
HuM195 is a humanized, unconjugated, anti-CD33 monoclonal antibody. Fifty adult patients with relapsed or refractory AML were randomized to receive HuM195 at a dose of 12 or 36 mg/m2 by intravenous infusion over 4 h on days 1–4 and 15–18. Patients with stable or responding disease received two additional cycles on days 29–32 and 43–46. HuM195 was given as first salvage therapy in 24 patients and as second or subsequent salvage therapy in 26 patients. Pretreatment blast percentage in the marrow was between 5 and 30% in 20 patients with the others having blast counts greater than 30%. The median age of patients was 62 years (range 26–86) and CD33 was detected in 95% of patients for whom immunophenotyping was available. Of 49 evaluable patients, two complete and one partial remission were observed. All three responses were in patients treated at the 12 mg/m2 dose level and all had baseline blast percentages less than 30%. Decreases in blast counts ranging from 30 to 74% were seen in nine additional patients. Infusion-related events of fever and chills occurred in the majority of patients and were generally mild and primarily related to the first dose of antibody. No hepatic, renal or cardiac toxicities were observed and other adverse events such as nausea, vomiting, mucositis and diarrhea were uncommon or felt to be unrelated to HuM195. In addition, anti-HuM195 responses were not detected. HuM195 as a single agent has minimal, but observable, anti-leukemic activity in patients with relapsed or refractory AML and activity is confined to patients with low burden disease. No significant differences in clinical efficacy or toxicity were seen between the two dose levels of antibody. HuM195 was well tolerated with infusion-related fevers and chills the predominant toxicities seen. Meaningful clinical efficacy of this unconjugated monoclonal antibody may be realized only in patients with minimal residual disease, or in combination with chemotherapy.
Details
- Title: Subtitle
- Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 monoclonal antibody HuM195
- Creators
- E FELDMAN - New York Medical CollegeM KALAYCIO - Department of Hematology and Medical Oncology, The Cleveland Clinic, Cleveland, OH, United StatesD LEVITT - Protein Design Labs, Inc., Fremont, CA, United StatesN WEDEL - Protein Design Labs, Inc., Fremont, CA, United StatesG WEINER - Holden Comprehensive Cancer Center and the Department of Internal Medicine, University of Iowa, Iowa City, IA, United StatesS FRANKEL - Division of Hematology/Oncology, Vincent T Lombardi Cancer Reserch Center, Washington, DC, United StatesP SCHULMAN - Don Monti Division of Oncology, North Shore University Hospital, Manhasset, NY, United StatesL SCHWARTZBERG - The West Clinic, PC, Memphis, TN, United StatesJ JURCIC - Leukemia Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United StatesE VELEZ-GARCIA - Department of Medicine, Heamatology-Medical Oncology Section, University of Puerto Rico School of Medicine, San Juan, Puerto RicoK SEITER - Division of Oncology, New York Medical College, Valhalla, NY, United StatesD SCHEINBERG - Leukemia Service, Memorial Sloan-Kettering Cancer Center, New York, NY, United States
- Resource Type
- Journal article
- Publication Details
- Leukemia, Vol.17(2), pp.314-318
- Publisher
- Nature Publishing
- DOI
- 10.1038/sj.leu.2402803
- PMID
- 12592328
- ISSN
- 0887-6924
- eISSN
- 1476-5551
- Language
- English
- Date published
- 2003
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Pharmaceutical Sciences and Experimental Therapeutics; Internal Medicine
- Record Identifier
- 9984094392202771
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