NCT04226937

DLBCL Interim Response Evaluation for Customised Therapy

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• High-grade B-cell Lymphoma

Interventions

Type	Name	Description
OTHER	Not 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.

Timeline

• Start date: 2020-09-17
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2020-01-13
• Last updated: 2022-08-05

Locations

1 site across 1 country: United Kingdom