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New treatment option for Primary Mediastinal Large B-cell Lymphoma
Official title Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)
ClinicalTrials.gov ID: NCT04824950
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- All stages (I-IV)
- All IPI scores (0-5)
- With mediastinal involvement,
You likely can't join 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),
See the full eligibility 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...
- 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.
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.