Tumor- and plasma-informed, next-generation sequencing (NGS)-based patient-specific droplet digital (dd)PCR assay18F-fludeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT)
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.
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.
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
ctDNA occurrence — Up to 27 months 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.
ctDNA quantification — Up to 27 months 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.
Trial sites (1)
Facility
City
Region
Status
Department of Hematology, Aarhus University Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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