Actively Recruiting
CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
Led by Nordic Lymphoma Group · Updated on 2025-01-01
60
Participants Needed
5
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating circulating tumor DNA (ctDNA) to assess early treatment response in patients with primary central nervous system lymphoma (PCNSL) receiving standard first-line therapy aimed at cure. This international, prospective, multicenter observational study also examines clinical features, health-related quality of life, neurological status, and outcomes of newly diagnosed PCNSL patients in Nordic countries. The goal includes identifying new prognostic and predictive biomarkers through molecular analyses of tumor tissue, cerebrospinal fluid, and plasma samples. Participants receive standard of care first-line therapies with curative intent, such as MATRix chemotherapy combined with high-dose chemotherapy and autologous stem cell transplantation. Throughout treatment, diagnostic tumor tissue, cerebrospinal fluid, and blood plasma are collected for ctDNA and other translational analyses. Treatment responses are evaluated using the International PCNSL Collaborative Group (IPCG) criteria, with MRI scans centrally reviewed to identify new markers. Participants are involved in regular assessments including MRI imaging for diagnostic and response evaluation, collection of biological samples, and monitoring of neurological status and quality of life. The primary outcome measure is ctDNA analysis six months after starting first-line therapy. The study includes follow-up to monitor outcomes and safety, with participant involvement lasting throughout their course of standard treatment and assessments.
CONDITIONS
Brief Title
CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years at diagnosis
- Histologically or cytologically confirmed diffuse large B-cell lymphoma of the central nervous system
- No prior treatment for PCNSL (pre-treatment corticosteroids allowed)
- Fit for standard first-line curative therapy such as full-dose MATRix
- Able to provide voluntary written informed consent
- If temporarily incapacitated, consent can be given by a legally acceptable representative according to ICH-GCP guidelines
You will not qualify if you...
- Lymphoma outside the central nervous system
- History of prior hematological malignancy such as low grade B-cell lymphoma
- Psychiatric illness or condition other than PCNSL that interferes with understanding study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months from initiation of first-line therapy
Participants who undergo routine care are observed with blood samples collected to assess ctDNA levels.
Visits scheduled as part of routine care and sample collection
Trial Site Locations
Total: 5 locations
1
Helsinki University Hospital
Helsinki, Finland
Not Yet Recruiting
2
Kuopio University Hospital
Kuopio, Finland
Not Yet Recruiting
3
Oulu University Hospital
Oulu, Finland
Not Yet Recruiting
4
Tampere University Hospital
Tampere, Finland
Actively Recruiting
5
Turku University Hospital
Turku, Finland
Not Yet Recruiting
Research Team
M
Marjukka Pollari, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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