CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorNordic Lymphoma Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
ctDNA
Predictive value and sensitivity of CSF and plasma ctDNA
Time frame
6 months from initiation of 1st line therapySponsors and contacts
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Source ClinicalTrials.gov