DIRECT
Research type
Research Study
Full title
DLBCL Interim Response Evaluation for Customised Therapy (DIRECT)
IRAS ID
245777
Contact name
Daniel Hodson
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and the University of Cambridge
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
This study will focus on a form of blood cancer called lymphoma, the most common subtype of which is Diffuse Large B Cell Lymphoma (DLBCL). DLBCL is curable with chemotherapy in approximately 60% of patients. However, 40% of patients either fail to respond or relapse soon after treatment. Options for these patients are limited and most will die from their disease. Existing technology does not allow us to predict accurately in advance these high-risk patients.
Recent studies, including work at Cambridge University Hospitals - Haematology department, have identified a catalogue of genetic mutations that contribute to DLBCL. Emerging evidence suggests that the mutational profile of an individual tumour may define subtypes of disease. An extension of this concept, which will be tested in this study, is whether combinations of mutations exist that define in advance who will and will not respond to current treatment. Such information, could if evidenced to be clinically timely and reliable, may in the future be used to modify treatments early to match the molecular 'fingerprint' of tumours in those patients who are identified as at high-risk of treatment failure or disease relapse with current treatment and also potentially enable clinical trials of novel therapies to be targeted to match specific molecular 'fingerprints'.
Genetic tests will be performed on DNA from the diagnostic and from research blood tests taken before, during and after treatment and during follow-up at 6 and 12 months after end of treatment and at progression or relapse should this occur. Biopsy tissue from patients who progress or relapse will also be tested. Results will be correlated with clinical responses to treatment, including standard of care CT or PET-CT scans.
This feasibility study will test if it is possible to obtain this molecular information in a timely fashion and weather it is clinically meaningful.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0068
Date of REC Opinion
26 Mar 2020
REC opinion
Favourable Opinion