Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04824950

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

Led by Centre Henri Becquerel · Updated on 2021-04-01

87

Participants Needed

2

Research Sites

362 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient over 18 years of age
  • Newly diagnosed with diffuse primary B lymphoma of the mediastinum confirmed by biopsy according to WHO 2016 classification
  • Any disease stage (I-IV)
  • Any International Prognostic Index (IPI) score (0-5)
  • Mediastinal involvement present
  • Untreated except emergency corticosteroid therapy less than 2mg/kg/day for 7 days
  • Planned treatment with R-CHOP-14 or R-ACVBP using PET-CT guided strategy
  • Tumor uptake above liver background on pre-treatment FDG PET/CT with Deauville score 4 or higher
  • Signed informed consent before any study procedures
  • Affiliated with or beneficiary of a social protection plan
Not Eligible

You will not qualify if you...

  • 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
  • Under guardianship or curatorship
  • Pregnant or breastfeeding
  • Unable to understand the study or comply with study requirements due to language, psychological, or geographical reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Centre Hospitalier Lyon Sud

Lyon, France

Not Yet Recruiting

2

Centre Henri Becquerel

Rouen, France

Actively Recruiting

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Research Team

V

VINCENT CAMUS, MD

CONTACT

R

RICHARD DORIANE, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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