CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)

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.

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Key information

Conditions

Primary Central Nervous System (CNS) Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

ctDNA

Time frame: 6 months from initiation of 1st line therapy

Predictive value and sensitivity of CSF and plasma ctDNA

Study contacts

Contact information is provided by the study sponsor or research team.

Marjukka Pollari, MD, PhD

CONTACT

[email protected]

+358 3 311 611

Sponsors and collaborators

Lead sponsor

Nordic Lymphoma Group

Network

Registry information

Acronym: CAPCI

Important dates

Study start: 2025
Primary completion: 2030
Study completion: 2038
First posted: Jan 1, 2025
Registry last updated: Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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