Cell-free Tumor DNA as Minimal Residual Disease in Hodgkin Lymphoma Patients

Hodgkin Lymphoma Clinical Trial

Official title:

Cell-free Tumor DNA Analysis for Minimal Residual Disease Detection in Patients With Hodgkin Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254821
• Other study ID #: FED-HL-DNA001
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: February 3, 2026

Study information

• Verified date: November 2022
• Source: Federico II University
• Contact: Claudia Giordano, MD
• Phone: 0817464289
• Email: claudiagiordano91[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Molecular analysis identifies residual disease by overcoming the sensitivity of imaging methods and therefore has the potential for integrating with therapy provided by FDG-PET alone. It is a well known fact that tumor DNA circulating in plasma (ctDNA) reflects the mutational profile of tumor cells and can be used to non-invasively detect specific mutations of Hodgkin's lymphoma without the need for microdissecting the histological sample.

Description:

A clinical need, not yet met for the Hodgkin lymphoma disease, brings about the early and accurate identification of chemo-refractory patients who require stepping up of treatment as also, patients with good prognosis receiving treatment de-escalation.Molecular methods identify residual disease by overcoming the sensitivity of imaging methods and therefore have the potential to integrate the response to therapy provided by FDG-PET alone.

ctDNA modification from the basal time point to the interim can be used as a predictor of response to the ABVD scheme and as a complement to the interim-PET in the possible variation of the therapeutic schedule.

Clinical data and peripheral blood samples (20 ml in EDTA tubes and 20 ml in Cell-Free DNA BCT tubes) will be collected during the clinico/laboratory visits that are planned as per clinical routine at the time of diagnosis, at each cycle of chemotherapy, at the time of interim PET/CT, at the time of end of treatment PET/CT and during follow up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 3, 2026
• Est. primary completion date: February 3, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female adults 18 years or older

• Documented diagnosis of Hodgkin lymphoma (both classic and nodular predominant lymphocytes subtype) according to 2016 WHO classification

• Willing and able to comply with scheduled study procedures

• Evidence of a signed informed consent

• ECOG performance status 0-2 (or 3, if disease related)

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma
• Neoplasm, Residual

Locations

Country	Name	City	State
Italy	Federico II University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of interim ctDNA genotyping	Sensitivity of interim ctDNA genotyping in identifying chemorefractory patients or patients with good prognosis (patients who do not progress after 24 months)	24 months