Status:
RECRUITING
Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)
Lead Sponsor:
Centre Henri Becquerel
Conditions:
Primary Mediastinal Large B-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
The majority of studies with PMBL patients pinpoint the importance of being able to identify primary chemo refractory patients at an early stage, in order to be able to improve their prognosis. Indeed...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT04824950
Start Date
March 22 2021
End Date
March 1 2028
Last Update
April 1 2021
Active Locations (2)
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1
Centre Hospitalier Lyon Sud
Lyon, France
2
Centre Henri Becquerel
Rouen, France