NCT06755619|Recruiting
CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
CAPCI
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CAPCI
Sponsor study identifier
Secondary identifiers
OTHER · Tampere University Hospital
observational
60
1 country
5
Study Start
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2024
Actual (reported)January 1, 2025
Actual (reported)January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
ctDNA
Predictive value and sensitivity of CSF and plasma ctDNA
6 months from initiation of 1st line therapy
Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma
Helsinki University Hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Spinal fluid, peripheral blood, tumor tissue
First Submitted
December 4, 2024
First Posted
January 1, 2025
Study Start
January 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2030
Contact the study team to confirm eligibility.
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 1, 2025
Record last verified: 2024-12
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