Using ctDNA to assess early treatment response in primary CNS lymphoma

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

This study is testing if a new blood test that looks for tumor DNA can help doctors see how well the first treatment is working for patients with primary central nervous system lymphoma.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Nordic Lymphoma Group (network)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Helsinki and 4 other locations)
• Trial ID: NCT06755619 on ClinicalTrials.gov

What this trial studies

This international, prospective, multicenter trial aims to evaluate circulating tumor DNA (ctDNA) as a biomarker for early response assessment in patients with primary central nervous system lymphoma (PCNSL) undergoing standard of care first-line therapy. The study will collect diagnostic tumor tissue, cerebrospinal fluid, and plasma samples to analyze ctDNA and identify potential prognostic and predictive biomarkers. Secondary endpoints include assessing clinical characteristics, health-related quality of life, neurological status, and outcomes in newly diagnosed PCNSL patients in Nordic countries. Treatment responses will be evaluated using established criteria from the International PCNSL Collaborative Group.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed diffuse large B-cell lymphoma of the CNS who are eligible for curative intent first-line therapy.

Not a fit: Patients with lymphoma outside the CNS or a history of prior hematological malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel method for early assessment of treatment response in PCNSL, potentially leading to improved patient outcomes.

How similar studies have performed: While the use of ctDNA in other cancers has shown promise, this specific application in PCNSL is relatively novel and untested.

Eligibility criteria

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

Where this trial is running

Helsinki and 4 other locations

• Helsinki University Hospital — Helsinki, Finland (NOT_YET_RECRUITING)
• Kuopio University Hospital — Kuopio, Finland (NOT_YET_RECRUITING)
• Oulu University Hospital — Oulu, Finland (NOT_YET_RECRUITING)
• Tampere University Hospital — Tampere, Finland (RECRUITING)
• Turku University Hospital — Turku, Finland (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Marjukka Pollari, MD, PhD

Conditions: Primary Central Nervous System Lymphoma, PCNSL, ctDNA