High-grade B-cell Lymphoma
Conditions
Brief summary
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.
Detailed description
This will be done by integrating data and samples collected from patients undergoing standard of care treatment for high-grade B cell lymphoma Data will be integrated from 1. Clinical risk factors from the International Prognostic Index (IPI) 2. Up-front genomic subtype based on molecular profiling of diagnostic biopsy 3. Serial ctDNA monitoring during treatment. 4. Radiological response imaging
Interventions
OTHERNot Applicable as this is a translational, sample collection study.
Patients will take their normal standard of care treatment for their lymphoma, as per agreed with the patient's doctor. Blood samples will be collected at Baseline, during the first 3 cycles of Treatment, at End of Treatment, at 6- and 12-months after End of Treatment and at relapse/progression if applicable. Surplus Tissue biopsy will be collected at Baseline and at relapse/progression if applicable. In rare cases research-specific tissue biopsy may be collected if appropriate.
Sponsors
AstraZeneca
Cancer Research UK Cambridge Institute
Cambridge University Hospitals NHS Foundation Trust
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish a robust molecular monitoring pipeline. | 3-5 years |
| 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
| Measure | Time frame | Description |
|---|---|---|
| When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2. | 3-5 years | 1. Clinical risk factors from the International Prognostic Index (IPI) 2. Up-front genomic subtype based on molecular profiling of diagnostic biopsy 3. Serial ctDNA monitoring during treatment. 4. Radiological response imaging |
| 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 | — |
| Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma. | 5 years | — |
Other
| Measure | Time frame |
|---|---|
| Identification of the de novo somatic variants in high-grade B cell lymphoma from collected ctDNA and tissue samples. | 3-5 years |
| Assess the utility of ctDNA to track clonal evolution in patients undergoing treatment for high-grade B cell lymphoma. | 3-5 years |
Countries
United Kingdom
Contacts
Primary ContactSilvia Tarantino
Outcome results
None listed