DLBCL Interim Response Evaluation for Customised Therapy (DIRECT)

NHS Foundation Trust

Status: Enrolling

Conditions: High-grade B-cell Lymphoma

Treatments: Other: Not Applicable as this is a translational, sample collection study.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04226937

DIRECT

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.