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

ConditionPrimary Mediastinal Large B-cell Lymphoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Henri Becquerel

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patient who has already started chemotherapy treatment,

Contraindication to FDG PET-CT,

No mediastinal involvement,

Positive HIV serology,

Trial design

Design model

Single group

Treatments tested in this trial

  • Circulating tumor DNA monitoring

    Other intervention

    Monitoring of circulating tumor DNA after 2 and 4 cycles of chemotherapy

Treatment groups

87 Participants
are divided into 1 treatment group
Group A: Monitoring of Circulating Tumor DNAOther 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between circulating tumoral DNA detection and complete molecular response

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

Time frame
4 months

Secondary outcomes

1

Evaluation of complete metabolic response

Proportion of patient in complete metabolic response at the end of first line treatment

Time frame
at the end of first line treatment
2

Evaluation of response

Percentage of patients in complete metabolic response, partial metabolic response, stable disease or pregression after 4 cycles of chemotherapy

Time frame
At the end of 4 cycles of chemotherapy
3

Evaluation of response

Percentage of patients in complete metabolic response, partial metabolic response, stable disease or pregression at the end of treatment

Time frame
At the end of treatment
4

overall survival

Time between death and inclusion

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Henri Becquerel

Lead sponsor

Source ClinicalTrials.gov
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