Circulating Tumor DNA in Peripheral T-cell Lymphomas

NCT06362148 | Active Not Recruiting

• 1 other identifier: 1-10-72-134-23
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the feasibility of circulating tumor DNA (ctDNA) measurement in blood plasma for the applicability in prognostication, treatment evaluation and measurable residual disease (MRD) surveillance in a cohort of patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL).

Conditions

Peripheral T-cell Lymphoma; NK/T-Cell Lymphoma

Keywords

Liquid biopsy; Circulating Tumor DNA; ctDNA; Cell Free DNA; cfDNA; mutational profiling

Outcome Measures

Primary Outcomes (2)

• ctDNA occurrence

  Proportion of patients with one or more measurable genetic alterations detected in plasma ctDNA by a tumor-informed, NGS-based patient-specific droplet digital PCR assay at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.

  Up to 27 months

• ctDNA quantification

  Median ctDNA levels in plasma by a tumor- and plasma-informed, NGS-based patient-specific droplet digital PCR assay at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of treatment, 6 month, 12 month, 18 month and 24 month follow-up.

  Up to 27 months

Secondary Outcomes (6)

• Progression free survival

  Up to 5 years

• Overall survival

  Up to 5 years

• Radiographic assessment by PET/CT

  Up to 27 months

• Comparison of molecular and radiographic response

  Up to 27 months

• Spatial and temporal mutational homo- or heterogeneity

  Up to 27 months

Interventions

Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay DIAGNOSTIC_TEST

Blood sampling for circulating tumor DNA analysis at baseline, cycle 2 day 1, cycle 3 day 1, mid-treatment, end of induction/end of treatment, 100 day follow-up, 6 month, 12 month, 18 month and 24 month follow-up. Blood sampling will also be done in case of relapsing/refractory disease at any point prior to the abovementioned time points.

18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) DIAGNOSTIC_TEST

FDG-PET/CT performed at baseline, mid-treatment, end of induction/end of treatment and 6 month, 12 month, 18 month and 24 month follow-up.

Eligibility Criteria

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

Study Population

Patients with peripheral T-cell lymphomas managed at tertiary care hospitals in Denmark.

You may qualify if:

• Patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma.
• All primary systemic PTCL entities from the International Consensus Classification 2022.
• ≥18 years of age.
• Life expectancy of 3 months or longer.
• ECOG performance status 0-4 at study entry (PS4 only if lymphoma-induced).
• Measurable disease.
• Written informed consent.

You may not qualify if:

• T-cell prolymphocytic leukemia
• T-cell large granular lymphocytic leukemia
• Chronic lymphoproliferative disorder of NK cells
• Adult T-cell leukemia / lymphoma
• Aggressive NK-cell leukemia
• Primary cutaneous T-cell lymphoma such as Sézary syndrome and Mycosis fungoides.
• Primary cutaneous CD30 positive T-cell lymphoproliferative disorders.
• Lymphomatoid papulosis.
• Primary cutaneous anaplastic large cell lymphoma.
• Primary cutaneous small/medium CD4-positive T-cell lymphoproliferative disorder.
• Primary cutaneous gamma-delta T-cell lymphoma.
• Primary cutaneous acral CD8-positive T-cell lymphoproliferative disorder.
• Primary cutaneous CD8-positive aggressive epidermotropic cytotoxic T-cell lymphoma.
• History of active cancer during the past year, except basal cell carcinoma of the skin or stage 0 cervical carcinoma (in situ).
• Unwillingness or inability to comply with the study protocol.

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Department of Hematology, Aarhus University Hospital

Aarhus, Central Jutland, 8200, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Diagnostic tumor biopsies Peripheral blood mononuclear cells Blood plasma

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Francesco A d'Amore, MD, DMSc

  Aarhus University Hospital and Aarhus University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 12, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)