Clinical trial · Interventional
Circulating Tumor DNA in Primary Mediastinal Large B-cell Lymphoma (PMBL)
NCT04824950CI-TRIAL-00051021CAMILrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Mediastinal Large B-cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating tumor DNA monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Monitoring of Circulating Tumor DNA
- interventionNames
- Other: Circulating tumor DNA monitoring
Primary outcomes (1)
- measure
- Correlation between circulating tumoral DNA detection and complete molecular response
- timeFrame
- 4 months
- description
- specificity of ctDNA at Cycle 2 of chemotherapy on the prediction of achieving a complete metabolic response (determined by PET-CT scan) at cycle 4 of chemotherapy
Secondary outcomes (8)
- measure
- Evaluation of complete metabolic response
- timeFrame
- at the end of first line treatment
- description
- Proportion of patient in complete metabolic response at the end of first line treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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 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 Criteria: * 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.).
References
Publications (0)
Data not yet available
No reference posted for this study.