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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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02961881
Study type Interventional
Source Amgen
Contact
Status Completed
Phase Phase 1
Start date September 18, 2017
Completion date September 2, 2021
View Details
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