Evaluating responses in high-grade B-cell lymphoma for personalized therapy
DLBCL Interim Response Evaluation for Customised Therapy
This study is testing a new way to find the best treatments for people with high-grade B-cell lymphoma by looking at their genes and how they respond to initial therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust Academic / other |
| Locations | 1 site (Cambridge, Cambridgeshire) |
| Trial ID | NCT04226937 on ClinicalTrials.gov |
What this trial studies
This study aims to create a comprehensive pipeline to identify patients with high-grade B-cell lymphoma who are most suitable for novel clinical trials based on their genomic subtype and early response to first-line therapy. It integrates clinical risk factors, genomic profiling from diagnostic biopsies, serial monitoring of circulating tumor DNA (ctDNA), and radiological imaging responses. By collecting and analyzing this data, the study seeks to enhance the precision of treatment strategies for patients with this aggressive form of lymphoma.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a histologically confirmed diagnosis of previously untreated high-grade B-cell lymphoma who are planned to receive immunochemotherapy.
Not a fit: Patients who cannot receive immunochemotherapy due to co-morbidities or personal choice, or those who have already started high-dose steroids for their lymphoma, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with high-grade B-cell lymphoma.
How similar studies have performed: Other studies have shown promise in using genomic profiling and early response evaluations to tailor treatments for various cancers, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
* Have given written informed consent to participate. * Age ≥ 18 years at the time of consent. * Histologically confirmed diagnosis of previously untreated high-grade B cell lymphoma. * Planned to receive immunochemotherapy as first-line therapy, e.g. R-CHOP therapy. * Planned or completed standard of care imaging (CT or PET-CT) * Able to give blood. Exclusion Criteria: * Unable to receive immunochemotherapy as first-line therapy due to co-morbidity or personal choice. * Patients who have already started high dose steroids as a treatment for their lymphoma. * Known diagnosis of infectious blood-borne virus e.g. Hep B, Hep C or HIV.
Where this trial is running
Cambridge, Cambridgeshire
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, Cambridgeshire, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Daniel Hodson, PhD MRCP FRCPath — Cambridge University Hospitals NHS Foundation Trust
- Study coordinator: Silvia Tarantino
- Email: silvia.tarantino@addenbrookes.nhs.uk
- Phone: +44(0)122325634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.