Actively Recruiting
Circulating Tumor DNA for Early Response Assessment in Primary Central Nervous System Lymphoma Treated with First Line Curative Therapy
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
Researchers are conducting an international, prospective, multicenter trial to study circulating tumor DNA (ctDNA) for early response evaluation in patients with primary central nervous system lymphoma (PCNSL) undergoing first-line standard of care therapy with curative intent. The study also aims to assess clinical features, quality of life, neurological status, and outcomes of newly diagnosed PCNSL patients in Nordic countries. Samples of tumor tissue, cerebrospinal fluid, and plasma will be collected to identify new prognostic and predictive biomarkers. Eligible patients will receive standard first-line therapies such as the MATRix regimen combined with high-dose chemotherapy and autologous stem cell transplantation, depending on local practice. Treatment responses will be evaluated using the International PCNSL Collaborative Group (IPCG) criteria, and MRI images will be centrally reviewed to discover additional biomarkers. The trial involves collecting diagnostic and response assessment data to better understand treatment effects. During the study, participants will undergo assessments including ctDNA measurement six months after starting therapy, clinical evaluations, health-related quality of life questionnaires, neurological examinations, and MRI scans. The researchers will monitor treatment response and safety, aiming to improve prognostic tools and patient outcomes. Participation involves providing informed consent and attending scheduled visits for sample collection and clinical follow-up.
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
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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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