Last updated on November 2019

A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma


Brief description of study

Primary Objective:

To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations

Secondary Objectives:

  • To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations
  • To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously
  • To determine the incidence of anti-blinatumomab antibody formation following SC administration
  • To evaluate efficacy response following treatment with SC blinatumomab administration

Exploratory Objective:

  • To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration
  • To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation

Clinical Study Identifier: NCT02961881

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Richmond, Australia
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Fitzroy, Australia
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