DLBCL Interim Response Evaluation for Customised Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-17

Study Completion Date

2025-09-01

Brief Summary

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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.

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Detailed Description

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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

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High-grade B-cell Lymphoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No