Epratuzumab, a humanized anti-CD22 antibody, in aggressive non-Hodgkin's lymphoma: phase I/II clinical trial results. Academic Article uri icon

Overview

MeSH

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Humanized
  • Antigens, CD
  • Antigens, Differentiation, B-Lymphocyte
  • Antineoplastic Agents
  • Cell Adhesion Molecules
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Half-Life
  • Humans
  • Infusions, Intravenous
  • Lectins
  • Lymphoma, B-Cell
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Safety
  • Sialic Acid Binding Ig-like Lectin 2
  • Time Factors

MeSH Major

  • Antibodies, Monoclonal
  • Lymphoma, Non-Hodgkin

abstract

  • We conducted a single-center, dose-escalation study evaluating the safety, pharmacokinetics, and efficacy of epratuzumab, an anti-CD22 humanized monoclonal antibody, in patients with aggressive non-Hodgkin's lymphoma. Epratuzumab was administered once weekly for 4 weeks at 120-1000-mg/m2 doses to 56 patients [most (n = 35) with diffuse large B-cell lymphoma]. Patients were heavily pretreated (median, 4 prior therapies), 25% received prior high-dose chemotherapy with stem cell transplant, and 84% had bulky disease (> or =5 cm). Epratuzumab was well tolerated, with no dose-limiting toxicity. Most (95%) infusions were completed within 1 h. The mean serum half-life was 23.9 days. Across all dose levels and histologies, objective responses (ORs) were observed in five patients (10%; 95% confidence interval, 3-21%), including three complete responses. In patients with diffuse large B-cell lymphoma, 15% had ORs. Overall, 11 (20%) patients experienced some tumor mass reduction. Median duration of OR was 26.3 weeks, and median time to progression for responders was 35 weeks. Two responses are ongoing at > or =34 months, including one rituximab-refractory patient. These data demonstrate that epratuzumab has a good safety profile and exerts antitumor activity in aggressive non-Hodgkin's lymphoma at doses of > or =240 mg/m2, thus warranting further evaluation in this clinical setting.

publication date

  • August 15, 2004

has subject area

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal
  • Antibodies, Monoclonal, Humanized
  • Antigens, CD
  • Antigens, Differentiation, B-Lymphocyte
  • Antineoplastic Agents
  • Cell Adhesion Molecules
  • Combined Modality Therapy
  • Dose-Response Relationship, Drug
  • Female
  • Follow-Up Studies
  • Half-Life
  • Humans
  • Infusions, Intravenous
  • Lectins
  • Lymphoma, B-Cell
  • Lymphoma, Non-Hodgkin
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Safety
  • Sialic Acid Binding Ig-like Lectin 2
  • Time Factors

Research

keywords

  • Clinical Trial
  • Clinical Trial, Phase I
  • Clinical Trial, Phase II
  • Journal Article

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1158/1078-0432.CCR-04-0294

PubMed ID

  • 15328168

Additional Document Info

start page

  • 5327

end page

  • 5334

volume

  • 10

number

  • 16