NCT04824950 Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)
| NCT ID | NCT04824950 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Henri Becquerel |
| Condition | Primary Mediastinal Large B-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 87 participants |
| Start Date | 2021-03-22 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 87 participants in total. It began in 2021-03-22 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare the predictive value in terms of specificity of circulating tumor DNA (ctDNA) and positron emission computed tomography (PET-CT) after 2 cycles of chemotherapy (C2), on the probability of obtaining a metabolic complete response after 4 cycles of induction chemotherapy (C4) in patients with primary mediastinal large B cell lymphoma (PMBL) receiving standard R-CHOP14 or R-ACVBP.
Eligibility Criteria
Inclusion Criteria: * Patient over 18 years of age, * Suffering from a diffuse primary B lymphoma of the mediastinum, newly diagnosed locally on a biopsy with anatomopathological analysis according to the recommendations of the WHO 2016 classification of hematological malignancies, * All stages (I-IV) * All IPI scores (0-5) * With mediastinal involvement, * Untreated (apart from emergency corticosteroid therapy less than 2mg/kg/day for 7 days), * Treatment with R-CHOP-14 or R-ACVBP with PET-CT guided strategy (delta SUVmax) to be initiated, * Tumor fixation above liver background on pre-treatment FDG PET/CT/CT (Deauville score ≥4), * Having signed the informed consent prior to any study procedure * Affiliated or beneficiary of a social protection plan. Exclusion Criteria: * Patient who has already started chemotherapy treatment, * Contraindication to FDG PET-CT, * No mediastinal involvement, * Positive HIV serology, * Positive hepatitis B or C serology with positive viral load, * Protected adult (under guardianship or curatorship), * Pregnant or breastfeeding women, * Patient unable to understand the study for any reason or to comply with the constraints of the trial (language, psychological, geographical problems, etc.).
Contact & Investigator
VINCENT CAMUS, MD
PRINCIPAL INVESTIGATOR
Centre Henri Becquerel
Frequently Asked Questions
Who can join the NCT04824950 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Mediastinal Large B-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04824950 currently recruiting?
Yes, NCT04824950 is actively recruiting participants. Contact the research team at vincent.camus@chb.unicancer.fr for enrollment information.
Where is the NCT04824950 trial being conducted?
This trial is being conducted at Lyon, France, Rouen, France.
Who is sponsoring the NCT04824950 clinical trial?
NCT04824950 is sponsored by Centre Henri Becquerel. The principal investigator is VINCENT CAMUS, MD at Centre Henri Becquerel. The trial plans to enroll 87 participants.