DLBCL Interim Response Evaluation for Customised Therapy

Cambridge University Hospitals NHS Foundation Trust150 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

150

Conditions

High-grade B-cell Lymphoma

Interventions

Not Applicable as this is a translational, sample collection study.OTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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.

Locations (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Establish a robust molecular monitoring pipeline.

Time frame: 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.

Time frame: 3-5 years

Secondary Outcomes

Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma.

Time frame: 5 years

Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, serial ctDNA response and radiological assessment (CT or PET-CT).

Time frame: 3-5 years

When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2.

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

Time frame: 3-5 years

Central Contacts

Silvia Tarantino

CONTACT

+44(0)122325634 silvia.tarantino@addenbrookes.nhs.uk

Data from ClinicalTrials.gov

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