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

NCT04824950 | Recruiting

• 1 other identifier: CHB20.03
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 2

Brief Summary

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

Primary Mediastinal Large B-cell Lymphoma

Keywords

Primary Mediastinal Large B-cell Lymphoma; Circulating tumor DNA; Next Generation sequencing

Outcome Measures

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

  4 months

Secondary Outcomes (8)

• Evaluation of complete metabolic response

  at the end of first line treatment

• Evaluation of response

  At the end of 4 cycles of chemotherapy

• Evaluation of response

  At the end of treatment

• overall survival

  3 years

• Event free survival

  3 years

Study Arms (1)

Monitoring of Circulating Tumor DNA

OTHER

Other: Circulating tumor DNA monitoring

Interventions

Circulating tumor DNA monitoring OTHER

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

Monitoring of Circulating Tumor DNA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.).

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (2)

Centre Hospitalier Lyon Sud

Lyon, France

NOT YET RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

Study Officials

• VINCENT CAMUS, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

• PIERRE SESQUES, MD

  Centre Hospitalier Lyon Sud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VINCENT CAMUS, MD

CONTACT

+33232082497; vincent.camus@chb.unicancer.fr

RICHARD DORIANE, PhD

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 1, 2021
• Study Start: March 22, 2021
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

FR (2)