NCT02961881

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: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	blinatumomab	Blinatumomab used as both continuous IV infusion and subcutaneous injection

Timeline

• Start date: 2017-09-18
• Primary completion: 2021-09-02
• Completion: 2021-09-02
• First posted: 2016-11-11
• Last updated: 2024-02-02
• Results posted: 2024-02-02

Locations

17 sites across 6 countries: United States, Australia, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated drug study