Evaluating blood tests for tumor DNA in peripheral T-cell lymphomas

Next-Generation Sequencing-based, Tumor- and Plasma-informed Droplet Digital PCR Assay for Detection of Circulating Tumor DNA in Peripheral T-cell Lymphomas

This study is testing if a blood test that looks for tumor DNA can help doctors track the progress of treatment in patients with newly diagnosed or relapsed peripheral T-cell lymphomas.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Aarhus (other)
• Locations: 1 site (Aarhus, Central Denmark Region)
• Trial ID: NCT06362148 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the feasibility of measuring circulating tumor DNA (ctDNA) in blood plasma for patients with newly diagnosed or relapsed/refractory peripheral T-cell lymphomas (PTCL). Participants will undergo a diagnostic tumor biopsy and provide a baseline plasma sample for targeted next-generation sequencing (NGS) to identify tumor-specific genetic alterations. A patient-specific droplet digital PCR assay will be developed to detect ctDNA at diagnosis and during treatment, alongside regular PET/CT scans for comparative analysis. The study will involve active participation for up to 27 months, with follow-up for survival analysis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with newly diagnosed or relapsed/refractory peripheral T-cell lymphoma.

Not a fit: Patients with specific types of T-cell leukemias or cutaneous T-cell lymphomas may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance prognostication and treatment monitoring for patients with peripheral T-cell lymphomas.

How similar studies have performed: Other studies utilizing ctDNA for monitoring treatment response in various cancers have shown promising results, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Aarhus, Central Denmark Region

• Department of Hematology, Aarhus University Hospital — Aarhus, Central Denmark Region, Denmark (RECRUITING)

Study contacts

• Principal investigator: Patrick R Noerhave, MD — Aarhus University Hospital and Aarhus University
• Study coordinator: Patrick R Noerhave, MD

Conditions: Peripheral T-cell Lymphoma, NK/T-Cell Lymphoma, Liquid biopsy, Circulating Tumor DNA, ctDNA, Cell Free DNA, cfDNA, mutational profiling