Phase 1b Study of Blinatumomab in Patients with Non-Hodgkin’s Lymphoma
Research type
Research Study
Full 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
IRAS ID
270469
Contact name
Nicholas Morley
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2016-002034-76
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 16 days
Research summary
Most indolent Non-Hodgkin’s Lymphoma (NHL) patients cannot be cured by conventional chemotherapy and most relapse until inevitably dying from their disease. Current evidence demonstrates a dose dependent clinical response of NHL patients treated with intravenous (IV) Blinatumomab. This study tests subcutaneous (SC) administration of Blinatumomab for the first time in humans. The SC delivery simplifies administration, improves convenience and reduces risks and costs. This study aims to demonstrate that Blinatumomab administered subcutaneously is as safe and effective as intravenously for subjects with relapsed/refractory indolent NHL.
Participants on this study will undergo a 14 day screening period, a 14 week Blinatumomab treatment period, and around 30 days safety follow-up. Intensive hospitalization and sampling is required.
The first part of the study focuses on the determination of the maximum tolerated/tested SC dose. Cohorts of 6 evaluable subjects will be tested for a specific SC dose/frequency. Participants receive a first cycle consisting of a continuous dose-stepped IV run-in period for 3 weeks, followed by SC the 4th week of participation, and finishing with a further 2 weeks continuous IV infusion to complete 6 weeks of treatment. If participants derive benefit from treatment, an optional second cycle may also be given as a cIV.
The second part of the study assesses the SC maximal dose determined from Period 1 for additional safety and efficacy data. An expanded cohort of up to 15 evaluable subjects will be tested with SC treatment only. Participants receive a first cycle consisting of a SC run-in period and then the selected maximal dose/frequency from Period 1 to complete 6 weeks of treatment. If participants derive benefit from treatment, an optional second cycle may also be given as a cIV or SC.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0622
Date of REC Opinion
24 Jan 2020
REC opinion
Further Information Favourable Opinion