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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Central Nervous System (CNS) Lymphoma

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Marjukka Pollari, MD, PhD; Phone Number: +358 3 311 611; Email: marjukka.pollari@pirha.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Not yet recruiting
    • Helsinki University Hospital
    • Contact: Susanna Mannisto; Phone Number: +358504279491; Email: susanna.mannisto@hus.fi
  • Kuopio, Finland
    • Not yet recruiting
    • Kuopio University Hospital
    • Contact: Katja Marin; Phone Number: +358447179959; Email: katja.marin@pshyvinvointialue.fi
  • Oulu, Finland
    • Not yet recruiting
    • Oulu University Hospital
    • Contact: Hanne Kuitunen; Phone Number: +358405050818; Email: hanne.kuitunen@pohde.fi
  • Tampere, Finland
    • Recruiting
    • Tampere University Hospital
    • Contact: Marjukka Pollari; Phone Number: +3583311611; Email: marjukka.pollari@pirha.fi
    • Contact: Saara Ojala; Phone Number: +358405130063; Email: saara.ojala@pirha.fi
  • Turku, Finland
    • Not yet recruiting
    • Turku University Hospital
    • Contact: Taina Reunamo; Phone Number: +35823132809; Email: taina.reunamo@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ctDNA	Predictive value and sensitivity of CSF and plasma ctDNA	6 months from initiation of 1st line therapy

Collaborators and Investigators

• Sponsor: Nordic Lymphoma Group

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2038

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 31, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: ctDNA; PCNSL
• Other Study ID Numbers: 24020; NLG-PCNSL-01 (Other Identifier: Tampere University Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No