Clinical trial · Observational
DLBCL Interim Response Evaluation for Customised Therapy
NCT04226937CI-TRIAL-00060155DIRECTunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-grade B-cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Not Applicable as this is a translational, sample collection study. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Establish a robust molecular monitoring pipeline.
- timeFrame
- 3-5 years
- measure
- 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.
- timeFrame
- 3-5 years
Secondary outcomes (3)
- measure
- Assess the utility of serial ctDNA assessment as a predicator of clinical outcome in high-grade B cell lymphoma.
- timeFrame
- 5 years
- measure
- Assess the utility of integrated data from clinical risk factors (IPI), up-front genotype, serial ctDNA response and radiological assessment (CT or PET-CT).
- timeFrame
- 3-5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* 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.
References
Publications (0)
Data not yet available
No reference posted for this study.