DLBCL Interim Response Evaluation for Customised Therapy

NCT04226937 | Unknown

• 1 other identifier: DIRECT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

High-grade B-cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Establish a robust molecular monitoring pipeline.

  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.

  3-5 years

Secondary Outcomes (3)

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

  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).

  3-5 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

Other Outcomes (2)

• Identification of the de novo somatic variants in high-grade B cell lymphoma from collected ctDNA and tissue samples.

  3-5 years

• Assess the utility of ctDNA to track clonal evolution in patients undergoing treatment for high-grade B cell lymphoma.

  3-5 years

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with diffuse Large B Cell Lymphoma (DLBCL) or closely related high-grade B cell lymphomas including, but not limited to: * DLBCL NOS * Transformed follicular lymphoma * High grade B cell lymphoma with rearrangement of BCL2/BCL6 and MYC * Plasmablastic lymphoma * Primary Mediastinal Large Cell lymphoma * Burkitt lymphoma * Primary Central Nervous System lymphoma * High grade B cell lymphoma NOS Undergoing Standard of Care treatment for their lymphoma.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• AstraZeneca: collaborator
• Cancer Research UK Cambridge Institute: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

ctDNA and Biopsy Tissue

Study Officials

• Daniel Hodson, PhD MRCP FRCPath

  Cambridge University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Tarantino

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 13, 2020
• Study Start: September 17, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)