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

  • STATUS
    Not Recruiting
  • participants needed
    65
  • sponsor
    Amgen
Updated on 20 August 2022
Investigator
Amgen Call Center
Primary Contact
Research Site (0.0 mi away) Contact
+21 other location
ct scan
chronic lymphocytic leukemia
hodgkin's disease
monoclonal antibodies
measurable disease
follicular lymphoma
mantle cell lymphoma
marginal zone lymphoma
anti-cd20 monoclonal antibody
indolent lymphoma

Summary

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

Details
Condition Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma, Non-Hodgkin's Lymphoma, non-hodgkin's lymphoma (nhl)
Treatment Blinatumomab
Clinical Study IdentifierNCT02961881
SponsorAmgen
Last Modified on20 August 2022

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