Blinatumomab in High-risk Diffuse Large B-Cell Lymphoma (DLBCL)
Research type
Research Study
Full title
A Phase 2 Open-label Study Investigating the Safety and Efficacy of Blinatumomab After Frontline R-Chemotherapy in Adult Subjects With Newly Diagnosed High-risk Diffuse Large B-Cell Lymphoma (DLBCL)
IRAS ID
213782
Contact name
Nick Morley
Contact email
Sponsor organisation
Amgen Limited
Eudract number
2016-002190-35
Duration of Study in the UK
3 years, 6 months, 10 days
Research summary
This study is designed to investigate the safety and efficacy of Blinatumomab in the treatment of adult patients with newly diagnosed aggressive high-risk diffuse large B-Cell lyphoma (DLBCL). DLBCL is a rapidly progressing lymph gland cancer.
Blinatumomab is a newly developed antibody which helps the body's own immune system destroy the malignant B-cells. Blinatumomab has been approved by regulatory health agencies in multiple countries for use in people with Philadelphia chromosome-negative relapse/refractory B-cell precursor acute lymphoblastic leukemia. Blinatumomab is still experimental and not approved by any regulatory health agency for people with progressing lymph gland cancer.
Patients aged over 18 will be assessed for eligibility for the study. Patients with untreated, proven high-risk DLBLC, who meet the study requirements for enrollment and institutional criteria for a standard chemotherapy with Rituximab can be enrolled to the run-in period of the study, which includes 6 cycles of the chemotherapy with Rituximab. The run-in period takes about 21 weeks.
Patient who complete the run-in period successfully will be assigned to the treatment with blinatumomab. During the treatment patients will receive 1 or 2 cycles of blinatumomab. Blinatumomab is given continuously intravenously through an infusion pump. The cycle 1 of blinatumomab treatment is 8 weeks in duration of continues infusion. The cycle 2 is 4 weeks in duration of continuation infusion. The study will take about 18-20 months for individual patient, including long-term follow up period.
Patients will be closely monitored throughout the study for their safety and tolerability to blinatumomab and diseases status as well. Patients will undergo body scans to assess cancer bulks in a body, blood and urine tests, standard diseases assessment.
The study will be conducted in 34 hospitals departments of hematology in 6 countries across Europe and North America including the UK with 2 open sites.
Please see more at: http://www.hra.nhs.uk/news/research-summaries/?s=blinatumomab&research-type=&from=&to=REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0450
Date of REC Opinion
8 Dec 2016
REC opinion
Further Information Favourable Opinion