MEDI4736-NHL-001_Phase1/2_Durvalumab_lymphoma/CLL
Research type
Research Study
Full title
A phase 1/2, open label, multi-centre study to assess the safety and tolerability of Durvalumab (ANTI-PD-L1 antibody) as monotherapy and in combination therapy in subjects with lymphoma or chronic lymphocytic leukaemia
IRAS ID
192275
Contact name
Andrew Davies
Contact email
Sponsor organisation
Celgene Internatinal II Sarl
Eudract number
2015-003516-21
Clinicaltrials.gov Identifier
NIHR Clinical Research Network reference number, CANC - 5307
Duration of Study in the UK
8 years, 0 months, 0 days
Research summary
Summary of Research
This is a phase 1 and 2, open label study to assess the safety and tolerability of durvalumab as an individual therapy or in combination with other treatments for patients with lymphoma or Chronic Lymphocytic Leukaemia (CLL).
CLL is the most common leukaemia in North America and Europe with an incidence of 4.0 cases per 100,000 persons per year and has a median age of diagnosis of 72 years. In the UK there are 15,000 new cases of lymphoma every year with approximately 3000 attributable deaths.
Durvalumab is an antibody (a protein that works with your immune system) that attaches to a molecule known as “programmed-cell-death ligand 1” (PD-L1). Signals from PD-L1 help cancers avoid detection by the immune system. Durvalumab blocks these signals, interfering with the cancer’s ability to escape the immune system. Durvalumab alone, or in combination with other anti-cancer drugs, is not currently approved for the treatment of CLL or lymphoma.
The other study treatments being investigated in combination with durvalumab are approved for the treatment of lymphomas and/or CLL in many countries throughout the world.
The purpose of this study is to test the safety and effectiveness, as well as to define the appropriate dose and schedule of an investigational drug and investigational combination of drugs.
About 253 patients worldwide will take part in this study. The maximum time patients could be in the study is about 8 years, including follow-up, but most patients will be in the study for a shorter time: about 3 years.
Summary of Results
Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS)
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0093
Date of REC Opinion
13 Apr 2016
REC opinion
Further Information Favourable Opinion