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
Study Details
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
Protocol Summary
Subject grade of dose limiting toxicities (DLTs)
Timeframe: 37 months
Incidence of dose limiting toxicities (DLTs)
Timeframe: 37 months
Severity of dose limiting toxicities (DLTs)
Timeframe: 37 months
Adverse Events
Timeframe: 37 months
Blinatumomab PK parameters (clearance of blinatumomab) under cIV
Timeframe: 37 months
Blinatumomab PK parameters (volume of distribution of blinatumomab) under cIV
Timeframe: 37 months
Blinatumomab PK parameters (clearance of blinatumomab) under SC administrations
Timeframe: 37 months
Blinatumomab PK parameters (volume of distribution of blinatumomab) under SC administrations
Timeframe: 37 months
Maximum Tolerated Dose
Timeframe: 37 months
Incidence of anti-blinatumomab antibodies
Timeframe: 37 months
Overall Response Rate (ORR)
Timeframe: 37 months
Complete Response (CR)
Timeframe: 37 months
Partial Response (PR) as determined by best overall response (ORR) using Cheson criteria
Timeframe: 37 months