DLBCL Interim Response Evaluation for Customised Therapy

Recruiting

• Conditions: High-grade B-cell Lymphoma

• Registration Number: NCT04226937
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

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

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-09-17
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-04
• Last Update Posted: 2022-08-05
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Establish a robust molecular monitoring pipeline.	3-5 years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom