Primary Central Nervous System (CNS) LymphomaCAPCINCT06755619
CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
An observational study of Primary Central Nervous System (CNS) Lymphoma, run by Nordic Lymphoma Group at 5 sites in Finland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Central Nervous System (CNS) Lymphoma
- How many people
- 60 participants
- Where
- 5 sitesFinland
- Study dates
- 1 Jan 2025to 31 Dec 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Finland5 sites, 5 recruiting
- Not yet recruiting
Helsinki University Hospital
Helsinki
Susanna Mannisto, +358504279491, susanna.mannisto@hus.fi
- Not yet recruiting
Kuopio University Hospital
Kuopio
Katja Marin, +358447179959, katja.marin@pshyvinvointialue.fi
- Not yet recruiting
Oulu University Hospital
Oulu
Hanne Kuitunen, +358405050818, hanne.kuitunen@pohde.fi
- Recruiting
Tampere University Hospital
Tampere
Marjukka Pollari, +3583311611, marjukka.pollari@pirha.fi
Saara Ojala, +358405130063, saara.ojala@pirha.fi
- Not yet recruiting
Turku University Hospital
Turku
Taina Reunamo, +35823132809, taina.reunamo@tyks.fi
About this study
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.
- Keywords
- PCNSL, ctDNA
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA
Predictive value and sensitivity of CSF and plasma ctDNA
Measured: 6 months from initiation of 1st line therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System (CNS) LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Nordic Lymphoma Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755619
- Sponsor's protocol ID
- 24020
- Other IDs
- NLG-PCNSL-01
- Acronym
- CAPCI
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CtDNA for Early Response Assessment in PCNSL Treated with 1st Line Curative Intent (NLG-PCNSL-01)
- ClinicalTrials.gov ID
- NCT06755619
- Acronym / sponsor ID
- CAPCI / 24020
- Keywords
- PCNSL, ctDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nordic Lymphoma GroupResearch network
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed primary central nervous system diffuse large B-cell lymphoma
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ctDNA
Time frame: 6 months from initiation of 1st line therapy
Predictive value and sensitivity of CSF and plasma ctDNA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Central Nervous System (CNS) Lymphoma, run by Nordic Lymphoma Group at 5 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marjukka Pollari, MD, PhD (+358 3 311 611, marjukka.pollari@pirha.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA (time frame: 6 months from initiation of 1st line therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.