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
730 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18-70 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 temporarily incapacitated to give consent due to PCNSL, consent can be obtained from a legally acceptable representative according to ICH-GCP guidelines
You will not qualify if you...
- Lymphoma outside the CNS
- History of prior hematological malignancy, e.g. low grade B-cell lymphoma
- Psychiatric illness or condition, other than PCNSL, that could interfere with understanding study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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