High-grade B-cell Lymphoma Clinical Trial
— DIRECTOfficial title:
DLBCL Interim Response Evaluation for Customised Therapy
The aim of the DIRECT Study is to establish a robust pipeline to identify those patients with high-grade B cell lymphoma most suitable for novel agent clinical trials based upon genomic subtype and an integrated response evaluation determined early in first-line therapy.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 1, 2025 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Cambridge University Hospitals NHS Foundation Trust | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
Cambridge University Hospitals NHS Foundation Trust | AstraZeneca, Cancer Research UK Cambridge Institute |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Identification of the de novo somatic variants in high-grade B cell lymphoma from collected ctDNA and tissue samples. | 3-5 years | ||
Other | Assess the utility of ctDNA to track clonal evolution in patients undergoing treatment for high-grade B cell lymphoma. | 3-5 years | ||
Primary | Establish a robust molecular monitoring pipeline. | 3-5 years | ||
Primary | Successful identification of trackable mutations in collected samples. Feasibility will be met if more than 75% of the samples yield trackable mutations across the whole study. | 3-5 years | ||
Secondary | Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma. | 5 years | ||
Secondary | Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, serial ctDNA response and radiological assessment (CT or PET-CT). | 3-5 years | ||
Secondary | When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2. | Clinical risk factors from the International Prognostic Index (IPI)
Up-front genomic subtype based on molecular profiling of diagnostic biopsy Serial ctDNA monitoring during treatment. Radiological response imaging |
3-5 years |
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