Circulating Tumor DNA in Peripheral T-cell Lymphomas

NCT ID: NCT06362148

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2030-12-31

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).

Detailed Description

In this observational prospective cohort study the investigators want to test the use of minimal-invasive liquid biopsies (blood plasma) for the detection of ctDNA in patients with newly diagnosed or relapsed/refractory PTCL. In each enrolled patient a diagnostic tumor-containing tissue biopsy as well as a baseline plasma sample will be subject to targeted next-generation sequencing (NGS) with the aim of identifying tumor-specific genetic alterations and clonal T-cell receptor rearrangements. This testing will be performed on biopsies that have been obtained as a part of standard-of-care diagnostic evaluation for PTCL and no further invasive biopsies will be performed.

Based on the NGS-analysis, a droplet digital polymerase chain reaction (ddPCR) assay will be designed for each patient. ddPCR will be used to detect ctDNA in plasma at diagnosis and later at defined time points during treatment and in the follow-up period.

At the same defined time points PET/CT scans will be performed for later comparative analysis. PTCL patients routinely have PET/CT scans performed before the start of treatment, mid-treatment, at the end of treatment and after hematopoietic stem cell transplant when applicable. PET/CT scans will be conducted every 6 months for the first 2 years of routine follow-up.

Active patient participation (i.e. blood sampling for ctDNA analysis and PET/CT scans) is expected to last up to 27 months from inclusion. Follow-up for survival analysis will be done for up to 5 years from inclusion.

The investigators hypothesize that the NGS-based tumor- and plasma-informed ddPCR assay applied in this study, will provide a highly sensitive and specific tool for prognostication, response evaluation and detection of relapse in patients with PTCL.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

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.

Intervention Type: DIAGNOSTIC_TEST

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

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.

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco A d'Amore, MD, DMSc

Role: STUDY_CHAIR

Aarhus University Hospital and Aarhus University

Patrick R Noerhave, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital and Aarhus University

Locations

Department of Hematology, Aarhus University Hospital

Aarhus, Central Jutland, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Patrick R Noerhave, MD

Role: CONTACT

panoer@rm.dk

+4551543715

Facility Contacts

Patrick R Noerhave, MD

Role: primary

panoer@rm.dk

+4551543715

Francesco A d'Amore, MD, DMSc

Role: backup

frandamo@rm.dk

+4523708527

Other Identifiers

1-10-72-134-23

Identifier Type: -

Identifier Source: org_study_id