Clinical trial NCT06755619: CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
Official title: CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Primary Central Nervous System (CNS) Lymphoma
Keywords: PCNSL
ctDNA
Lead sponsor: Nordic Lymphoma Group
Sponsor class: NETWORK
First posted: 2025-01-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma

Brief summary: This is an international, prospective, multicenter trial with the aim of characterizing circulating tumor DNA (ctDNA) for early response assessment in PCNSL patients treated with standard of care (SOC) 1st line therapy with a curative intent (Figure 1). Secondary endpoints are to assess the clinical characteristics, health-related quality of life (HRQoL), neurological status, and outcome of newly diagnosed primary central nervous system lymphoma (PCNSL) patients in the Nordic countries. Patients eligible for a curative intent SOC 1st line therapy, such as MATRix + high-dose chemotherapy and autologous stem cell transplantation (HDCT/ASCT), are eligible for the trial. Diagnostic tumor tissue, cerebrospinal fluid (CSF), and plasma samples are collected for ctDNA and translational analyses with the aim describing new prognostic and predictive biomarkers. Treatment responses are assessed with the International PCNSL Collaborative Group (IPCG) response criteria, and diagnostic and response assessment magnetic resonance imaging (MRI) images are centrally analyzed in order to describe new prognostic and predictive markers.


Eligibility criteria: Inclusion Criteria:

* Age 18-70 years at diagnosis
* Histologically or cytologically verified diffuse large B-cell lymphoma (DLBCL) of the central nervous system (CNS)
* No prior treatment for PCNSL (pre-treatment corticosteroids are allowed and recommended)
* Fit for standard of care (SOC) 1st line therapy with a curative intent such as full-dose MATRix, according to local policy
* Able to give voluntary written informed consent
* If the patient is temporarily incapacitated to give the voluntary written informed consent, due to PCNSL, the informed consent can be obtained from a legally acceptable representative, according to the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use - Guideline for Good Clinical Practice (ICH-GCP) guidelines

Exclusion Criteria:

* Lymphoma outside the CNS
* History of prior hematological malignancy e.g. low grade B-cell lymphoma
* Psychiatric illness or condition, other than PCNSL, which could interfere with the ability to understand the requirements of the study

Primary outcomes:
measure: ctDNA
timeFrame: 6 months from initiation of 1st line therapy
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
References: