Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 monoclonal antibody HuM195

E. J. Feldman, M. Kalaycio, G. Weiner, S. Frankel, P. Schulman, Lee Schwartzberg, J. Jurcic, E. Velez-Garcia, K. Seiter, D. Scheinberg, D. Levitt, N. Wedel

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)314-318
Number of pages5
JournalLeukemia
Volume17
Issue number2
DOIs
StatePublished - Feb 1 2003

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Acute Myeloid Leukemia
Monoclonal Antibodies
Therapeutics
Salvage Therapy
Chills
Fever
Immunophenotyping
Mucositis
Antibodies
Residual Neoplasm
Combination Drug Therapy
Intravenous Infusions
Nausea
Vomiting
Diarrhea
Bone Marrow

All Science Journal Classification (ASJC) codes

  • Hematology
  • Oncology
  • Cancer Research

Cite this

Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 monoclonal antibody HuM195. / Feldman, E. J.; Kalaycio, M.; Weiner, G.; Frankel, S.; Schulman, P.; Schwartzberg, Lee; Jurcic, J.; Velez-Garcia, E.; Seiter, K.; Scheinberg, D.; Levitt, D.; Wedel, N.

In: Leukemia, Vol. 17, No. 2, 01.02.2003, p. 314-318.

Research output: Contribution to journalArticle

Feldman, EJ, Kalaycio, M, Weiner, G, Frankel, S, Schulman, P, Schwartzberg, L, Jurcic, J, Velez-Garcia, E, Seiter, K, Scheinberg, D, Levitt, D & Wedel, N 2003, 'Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 monoclonal antibody HuM195', Leukemia, vol. 17, no. 2, pp. 314-318. https://doi.org/10.1038/sj.leu.2402803
Feldman, E. J. ; Kalaycio, M. ; Weiner, G. ; Frankel, S. ; Schulman, P. ; Schwartzberg, Lee ; Jurcic, J. ; Velez-Garcia, E. ; Seiter, K. ; Scheinberg, D. ; Levitt, D. ; Wedel, N. / Treatment of relapsed or refractory acute myeloid leukemia with humanized anti-CD33 monoclonal antibody HuM195. In: Leukemia. 2003 ; Vol. 17, No. 2. pp. 314-318.
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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.",
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