A phase I study of dacetuzumab (SGN-40, a humanized anti-CD40 monoclonal antibody) in patients with chronic lymphocytic leukemia. Academic Article uri icon

Overview

MeSH

  • Adult
  • Aged
  • Aged, 80 and over
  • Anorexia
  • Antibodies, Monoclonal, Humanized
  • Conjunctivitis
  • Dose-Response Relationship, Drug
  • Fatigue
  • Female
  • Headache
  • Humans
  • Male
  • Middle Aged
  • Treatment Outcome

MeSH Major

  • Antibodies, Monoclonal
  • Leukemia, Lymphocytic, Chronic, B-Cell

abstract

  • Despite advances in therapy, chronic lymphocytic leukemia remains an incurable disease and novel, effective therapies are needed. In this open-label, dose-escalation, phase I study, dacetuzumab (IgG1 humanized monoclonal antibody) was administered to 12 adults, all of whom had received several prior systemic therapies (median, 4; range, 2-11). Intrapatient dose escalation (maximum weekly doses of 3-8 mg/kg) was used to diminish first-dose-related inflammatory symptoms. No dose-limiting toxicities or dose-dependent trends in adverse events (AEs) were observed. The most common AEs (in >/=2 patients) were fatigue, headache, anorexia, conjunctivitis, hyperhidrosis, and night sweats, all of which were mild or moderate. No deaths, serious AEs, or discontinuations due to AEs occurred. Although no patient achieved an objective response, five patients demonstrated stable disease after 1 cycle of therapy, with no discernable correlation between dacetuzumab dose and outcome. This modest single-agent activity may warrant further testing of dacetuzumab in combination with other chronic lymphocytic leukemia therapies.

publication date

  • February 2010

has subject area

  • Adult
  • Aged
  • Aged, 80 and over
  • Anorexia
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Conjunctivitis
  • Dose-Response Relationship, Drug
  • Fatigue
  • Female
  • Headache
  • Humans
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Male
  • Middle Aged
  • Treatment Outcome

Research

keywords

  • Clinical Trial, Phase I
  • Journal Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.3109/10428190903440946

PubMed ID

  • 20038235

Additional Document Info

start page

  • 228

end page

  • 235

volume

  • 51

number

  • 2