Phase II/III of MOR00208 with BEN versus Ritux with BEN in R/R DLBCL
Research type
Research Study
Full title
A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT) – B-MIND
IRAS ID
203949
Contact name
Rod Johnson
Contact email
Sponsor organisation
MorphoSys AG
Eudract number
2014-004689-11
Duration of Study in the UK
3 years, 6 months, 14 days
Research summary
This is a phase II/III study for patients suffering from Diffuse Large B-cell Lymphoma that has come back or is not fully responding to treatment. Cancer cells are different than normal cells in the body and are recognised by the immune system. In some cases the immune system may control or even get rid of cancer cells. However, sometimes the immune system does not see the cancer cells as foreign because the cells are not different enough from normal cells. In other cases the immune system recognises the cancer cells, but the response might not be strong enough to destroy the cancer.
The drug investigated in this study, MOR00208, is being investigated as an anti-cancer drug that helps the body’s immune system to recognise and destroy cancer cells. MOR00208 is an antibody that binds to the surface of cancer cells and thereby helps the immune system to destroy cancer cells.
The purpose of this research study is to compare the effects and safety of the study drug, MOR00208, given with Bendamustine (BEN) to another treatment combination, Rituximab (RTX) in combination with BEN to find out which combination is better for treating DLBCL.
The study is randomised (patients will be assigned one of two treatment groups), multicentre and open label (the patient and doctor will know the assigned treatment arm).The study is split into three sections, screening – to check for eligibility, treatment and follow up. If a patient is deemed eligible according to the screening criteria they will be randomised to one of the two treatment groups. During the treatment phase, patients will complete 28 day treatment cycles according to following schedule:
BEN + MOR00208; Cycles 1 to 3 on Day 1, 4 (cycle 1 only) 8, 15 and 22. During cycles 4 – 25 patients will attend on days 1 and 15.
BEN + RTX; Patients will attend on day 1 and 2 or Day 2 and 3
When a patient is removed from the study they will undergo safety assessments and will be followed up for disease assessment.
The study will take place at 4 NHS hospital sites in the UK and 8 patients are expected to be enrolled. A total of approximately 330 patients will be recruited worldwide.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
16/NE/0169
Date of REC Opinion
9 Jun 2016
REC opinion
Further Information Favourable Opinion