Using ctDNA to assess early treatment response in primary CNS lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tampere University Hospital
  Tampere, Finland Recruiting
• Helsinki University Hospital
  Helsinki, Finland Not yet recruiting
• Kuopio University Hospital
  Kuopio, Finland Not yet recruiting
• Oulu University Hospital
  Oulu, Finland Not yet recruiting
• Turku University Hospital
  Turku, Finland Not yet recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• R-PMDT Regimen for Newly Diagnosed PCNSL

  This study tests the R-PMDT treatment approach in people newly diagnosed with primary CNS lymphoma to see how many respond.

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• MB-CART19.1 cellular therapy for people with central nervous system lymphoma

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• Rapid CSF ctDNA Test and Treatment Monitoring for Primary CNS Lymphoma

  This study tests whether CSF circulating tumor DNA can quickly diagnose primary CNS lymphoma and monitor response to treatment in adults.

  Recruiting Beijing Tiantan Hospital · Beijing, Beijing Municipality · NCT07851363

• Testing a four-drug regimen (methotrexate, rituximab, sintilimab, pirtobrutinib) versus investigator-selected care for newly diagnosed PCNSL

  This trial will try a combination of methotrexate, rituximab, sintilimab and pirtobrutinib as first treatment for adults with newly diagnosed primary central nervous system lymphoma to see if it increases complete remissions and is safe compared with standard doctor-selected treatments.

  Recruiting at 3 sites Phase 2 Tongji Hospital · Xiamen, Fujian and 3 other locations · NCT07350850

• Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

  In this study, adults with newly diagnosed primary CNS lymphoma try different induction regimens to see which one works best before consolidation therapy.

  Recruiting at 9 sites Phase 2/3 Huashan Hospital · Beijing and 14 other locations · NCT07185373

• Epcoritamab plus ibrutinib for central nervous system lymphoma

  This trial tests whether combining epcoritamab and ibrutinib is safe and tolerable for adults with relapsed or refractory primary or secondary central nervous system lymphoma.

  Recruiting at 8 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 7 other locations · NCT07082868

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.