Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02339805
• Date of registration: 13/01/2015
• Prospective Registration: No
• Primary sponsor: Centre Henri Becquerel
• Public title: Assessment of the Minimal Residual Disease in DLBCL From Cell-free Circulating DNA by NGS LymphoSeq
• Scientific title: Assessment of the Minimal Residual Disease in Diffuse Large B-Cell Lymphomas (DLBCL) From Cell-free Circulating DNA by Next Generation Sequencing (NGS)
• Date of first enrolment: November 1, 2014
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02339805
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Fabrice Jardin, Professor
• Affiliation: Centre Henri Becquerel

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age up to 18 years old

- With a diagnosis formally established of DLBCL or transformed straightaway follicular
lymphoma or 3B grade follicular lymphoma or Burkitt-like lymphoma

- Eligible to a treatment by immunochemotherapy like R-CHOP, R-ACVBP or R-CHOP like

- First line of treatment

- Being able to benefit from standard extension assessment ( Fluorine-18
fluorodeoxyglucose positron emission tomography (18F-FDG-PET) and bone marrow biopsy
with a bone marrow aspiration)

- Written informed consent

- Tumor biopsy used for diagnosis available

Exclusion Criteria:

- Patient who cannot receive polychemotherapy like R-CHOP, R-ACVBP, or R-CHOP like

- Patient who cannot benefit from standard extension assessment and follow-up by with
Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

- Pregnant or breast-feeding woman

- Guardianship, curatorship

- Patient who cannot follow the medical procedures of the study for geographic, social,
psychological,linguistic or physical reasons



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Non Hodgkin Lymphoma

Intervention(s)

Device: Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)

Other: next generation sequencing

Primary Outcome(s)

Determine the clonal evolution during and after treatment by Next Generation Sequencing [Time Frame: one year]

Secondary Outcome(s)

Assess the clonal architecture in tumor DNA and bone marrow [Time Frame: one year]

Progression free survival [Time Frame: One year]

Compare the Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) procedure and the kinetic and pattern of somatic mutations identified in cfDNA [Time Frame: one year]

Overall survival [Time Frame: one year]

Secondary ID(s)

CHB13.03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

U918 ( Inserm unit)