Blinatumomab in Aggressive B-Cell Non Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects with Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma
IRAS ID
211812
Contact name
Andrew McMillan
Contact email
Sponsor organisation
Amgen Ltd
Eudract number
2016-002044-16
Duration of Study in the UK
1 years, 4 months, 29 days
Research summary
Diffuse Large B-Cell Lymphoma (DLBCL) is the most common subtype of Non-Hodgkin’s lymphoma (NHL), a cancer that forms in cells called lymphocytes, which are a part of the body’s immune system. Commonly used regimens contain rituximab and chemotherapy. Patients who do not respond to this therapy are generally considered incurable unless able to receive either high-dose chemotherapy with hematopoietic stem cell transplant.
The purpose of this study is to understand the effectiveness, safety, and tolerability of blinatumomab for participants with relapsed/refractory aggressive B-Cell NHL. Blinatumomab connects tumor cells with T- cells. This close proximity assists T-cell killing of the attached tumor cell.
This open-label, multi-center trial will be conducted in two parts; effectiveness of blinatumomab monotherapy will be studied with around 36 participants in phase 2 and blinatumomab will be compared to investigator’s choice chemotherapy (ICC) where around 296 participants will be randomised on to either Blinatumomab or ICC in phase 3.
You will be asked to take part in pre-screening prior to being fully consented onto the study. Based on the results from your routine PET-CT scans you may be eligible to participate in the study and asked to fully consent. Participants will then enter the screening phase, following which eligible participants will begin receiving investigational product. The planned duration of involvement for each participant in phase 2 is approximately 30 months, including a 28-day screening period, up to 112 days of treatment, a 30-day safety follow up, and approximately a 2-year follow up. For patients who participate in phase 3, participation will be about 33 months.
Blinatumomab will be administered at the study site and also by trained nurses at home where applicable. During the study, participants will undergo a number of procedures and assessments, including physical examinations, blood tests, and reviews of adverse event and medication use.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0359
Date of REC Opinion
7 Sep 2016
REC opinion
Further Information Favourable Opinion