DIRECT

DLBCL Interim Response Evaluation for Customised Therapy

Research summary

This study focuses 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 the disease. An extension of this concept, which is being 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 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. This may create the opportunity to enable clinical trials of novel therapies to be targeted to match specific molecular 'fingerprints' of DLBCL.

Genetic tests are being performed on DNA from blood tests taken before, during and after treatment, during follow-up after treatment has ended and at progression or relapse should this occur. Biopsy tissue from patients who progress or relapse are also being tested. Results are being correlated with clinical responses to treatment. This feasibility study is testing if it is possible to obtain this molecular information in a timely fashion and whether it is clinically meaningful.

clinicaltrials.gov

integratedcancermedicine.org


Main inclusion criteria

  1. Have given written informed consent to participate

  2. Age ≥ 18 years at the time of consent

  3. Histologically confirmed diagnosis of previously untreated high-grade B cell lymphoma

  4. Planned to receive immunochemotherapy as first-line therapy, e.g. R-CHOP therapy

  5. Planned or completed standard of care imaging (CT or PET-CT)

  6. Able to give blood

Main exclusion criteria

  1. Unable to receive immunochemotherapy as first-line therapy due to co-morbidity or personal choice

  2. Patients who have already started high dose steroids as a treatment for their lymphoma

  3. Known diagnosis of infectious blood-borne virus e.g. Hep B, Hep C or HIV



Chief investigator

Dr Daniel Hodson

Contact details

Cancer Theme Email: cctu-cancer@addenbrookes.co.uk