Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab

Official Title

A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)

Summary:

This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma. This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma.

Trial Description

Primary Outcome:

  • Risk difference (RD) of objective response rate (ORR)
  • Risk difference (RD) of overall response rate (ORR)
Secondary Outcome:
  • Risk difference of ORR
  • Percent of subjects with complete depletion of CD19 cell count and total Immunoglobin G (IgG) and IgM antibody levels
  • Subject incidence of treatment-emergent AEs and serious adverse events
  • Incidence of anti-drug antibodies
  • On study progression-free survival
  • On study overall survival
  • Geometric mean ratio (GMR) of test (ABP 798)-to-reference (rituximab)

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society