RecruitingNot ApplicableNCT04824950

Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)

Sponsor

Centre Henri Becquerel

Enrollment

87 participants

Start Date

Mar 22, 2021

Study Type

INTERVENTIONAL

Conditions

Primary Mediastinal Large B Cell Lymphoma

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

Min Age: 18 Years

Inclusion Criteria10

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 Criteria8

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.).