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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04226937
Other study ID # DIRECT
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 17, 2020
Est. completion date September 1, 2025

Study information

Verified date August 2022
Source Cambridge University Hospitals NHS Foundation Trust
Contact Silvia Tarantino
Phone +44(0)122325634
Email silvia.tarantino@addenbrookes.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 1, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge Cambridgeshire

Sponsors (3)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust AstraZeneca, Cancer Research UK Cambridge Institute

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Identification of the de novo somatic variants in high-grade B cell lymphoma from collected ctDNA and tissue samples. 3-5 years
Other Assess the utility of ctDNA to track clonal evolution in patients undergoing treatment for high-grade B cell lymphoma. 3-5 years
Primary Establish a robust molecular monitoring pipeline. 3-5 years
Primary 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 Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma. 5 years
Secondary 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
Secondary When the pipeline is optimised can these 4 parameters be available within 6 weeks, i.e. by completion of Cycle 2. Clinical risk factors from the International Prognostic Index (IPI)
Up-front genomic subtype based on molecular profiling of diagnostic biopsy
Serial ctDNA monitoring during treatment.
Radiological response imaging
3-5 years
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