Kinetics of Circulating Tumor DNA in Lymphoma Treated by Immuno-chemotherapy

Diffuse Large B Cell Lymphoma Clinical Trial

— LYMPHO-CLEAR  

Official title:

Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06141772
• Other study ID #: CHB23.05
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: May 15, 2025

Study information

• Verified date: October 2023
• Source: Centre Henri Becquerel
• Contact: Fabrice Jardin, MD,PhD
• Phone: +33232082465
• Email: fabrice.jardin[@]chb.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the kinetics of circulating tumor DNA (ctDNA) in the hours following initial administration of immuno-chemotherapy to patients with diffuse large B cell lymphoma (DLBCL). Modelizing the short-term kinetics of ctDNA would help to determine the optimal time-point for ctDNA follow-up. The investigators hypothesize that the greater ctDNA release at this time-point compared to baseline might lead lead to the detection of novel variants compared to baseline.

Description:

ctDNA in diffuse large B cell lymphoma (DLBCL) has become an essential dynamic biomarker. Due to its short half-life, ctDNA is a real-time reflection of tumoral evolution and is a non-invasive biomarker that can be used for patient evaluation and follow-up. The quantity of ctDNA before treatment is correlated with tumoral mass, international prognostic index (IPI) and prognosis. The principal mechanism of ctDNA release is tumor cell apoptosis and it is well established that tumor cell apoptosis is observed in the hours following immuno-chemotherapy. However, the kinetics of ctDNA concentration in the hours following immuno-chemotherapy administration is unknown.

Modelizing the kinetics of ctDNA during this early timeframe could help to better predict chemo-sensitivity and better reflect genetic heterogeneity of the tumor, through release of a larger quantity of ctDNA compared to baseline.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: May 15, 2025
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Diffuse Large B Cell Lymphoma

• TEP-TDM at diagnosis

• Inform Consent form signed

• Performance status 0 or 1

• Hospitalized on clinician decision for first cycle of R-CHOP or R-miniCHOP

Exclusion Criteria:

• Histology other than Diffuse Large B Cell

• Patient under guardianship or curatorship

• Incapacity to understand the study or conform to the constraints of the study (language barrier, psychological barrier, geographic barrier…)

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Other:
• Measure of the circulating tumor DNA
Blood assessment to measure the kinetics au circulating tumor DNA

Locations

Country	Name	City	State
France	Centre Henri Becquerel	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Henri Becquerel

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of circulating tumor DNA kinetics	Blood assessment to measure circulating tumor concentration	21 days
Secondary	Correlation between circulating tumor DNA concentration and metabolic volume	comparison between circulating tumoral concentration and metabolic volume measured on TEP	6 months