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

Recruiting now · Not applicable

Conditions studied: Primary Mediastinal Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT04824950

Run by

Centre Henri Becquerel

People needed

87

Starts

2021-03-22

Expected to finish

2028-03-01

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• Centre Henri Becquerel — Rouen, France (enrolling)
• Centre Hospitalier Lyon Sud — Lyon, France

Full record on ClinicalTrials.gov

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