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

Sponsor
Centre Henri Becquerel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06141772
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
18
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Measure of the circulating tumor DNA
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Prospective Study of Circulating Tumor DNA Kinetics Post R-CHOP Type Treatment of Diffuse Large B Cell Lymphoma
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Nov 15, 2024
Anticipated Study Completion Date :
May 15, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kinetics of circulating tumor DNA

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

Outcome Measures

Primary Outcome Measures

  1. Analysis of circulating tumor DNA kinetics [21 days]

    Blood assessment to measure circulating tumor concentration

Secondary Outcome Measures

  1. Correlation between circulating tumor DNA concentration and metabolic volume [6 months]

    comparison between circulating tumoral concentration and metabolic volume measured on TEP

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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…)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Henri Becquerel Rouen France 76000

Sponsors and Collaborators

  • Centre Henri Becquerel

Investigators

  • Principal Investigator: Fabrice Jardin, MD,PhD, Centre Henri Becquerel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Henri Becquerel
ClinicalTrials.gov Identifier:
NCT06141772
Other Study ID Numbers:
  • CHB23.05
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Henri Becquerel
Diffuse Large B Celle Lymphoma
Circulating tumor DNA
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse

Study Results

No Results Posted as of Nov 21, 2023