Central Nervous System LymphomaNCT05114330
Secondary Central Nervous System Lymphoma Registry - Charité
An observational study of Central Nervous System Lymphoma and Non-Hodgkin Lymphoma, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Lymphoma, Non-Hodgkin Lymphoma
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jun 2011to 8 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with SCNSL
Who may be able to join
- All patients with SCNSL can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for SCNSL.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Stefan Habringer, MD contact
Germany1 site, 1 recruiting
- Recruiting
Charité - Universitätsmedizin, Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie (CBF)
Berlin, 12200
Ulrich Keller, MD, Prof., +4930 450513447, ulrich.keller@charite.de
Stefan Habringer, MD, +4930450613549, stefan.habringer@charite.de
About this study
Official title: Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice
The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. In particular, the following questions will be specified:
- What therapeutic approaches are being pursued?
- What is the clinical outcome of the various treatment options?
- What is the frequency of serious adverse events with each therapeutic approach?
Read the detailed description
The observational study is to be conducted in inpatient clinics, outpatient clinics and by oncology physicians in private practice. The investigators will be invited to participate by the Charité - CNS Lymphoma Working Group (Charité AG ZNSL) or the Competence Network Malignant Lymphomas (KML). When a patient is reported, the personal data of the physician including the patient will be recorded and compiled in the form of a list documentation.
All patients with SCNSL can and should be included in the study regardless of which therapy options are used and regardless of whether it is a first-line treatment, the treatment of a recurrence or a maintenance therapy for SCNSL. No intervention is associated with the conduct of the observational study with regard to the selection and implementation of the specific therapeutic regimen, diagnostics, and examination frequency during and after treatment.
The following information should be documented:
- Patient demographics and medical history
- Tumor extent at the time of initial diagnosis and CNS involvement
- Prior therapy
- General condition
- Therapy regimen for the CNS involvement
- Response
- Adverse drug reactions
- Tolerability of therapy: acute toxicity
- Chronic therapy toxicity, especially late neurotoxicity
- Time to treatment failure (relapse or progression)
- Death from any cause
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Systemic (= localized outside the CNS) lymphoma with secondary CNS involvement at initial diagnosis | |
| Cohort 2 | CNS relapse of previously systemic lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of different therapeutic regimens
Description of different therapeutic regimens
Measured: Through study completion, an average of 3 years
Outcome of different therapeutic regimens
Overall Survival
Measured: Through study completion, an average of 3 years
Outcome of different therapeutic regimens
Progression Free Survival
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start8 Jun 2011
- Primary completion8 Jun 2024 (estimated)
- Study completion8 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System LymphomaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Habringer, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114330
- Sponsor's protocol ID
- SZNSL-R
- Status last verified
- Nov 2023
- First submitted
- 25 Oct 2021
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Habringer S, Demel UM, Fietz AK, Lammer F, Schroers R, Hofer S, Bairey O, Braess J, Meier-Stiegen AS, Stuhlmann R, Schmidt-Hieber M, Hoffmann J, Zinngrebe B, Kaiser U, Reimer P, Mohle R, Fix P, Hoffkes HG, Langenkamp U, Buschenfelde CMZ, Hopfer O, Stoltefuss A, La Rosee P, Blasberg H, Jordan K, Kaun S, Meurer A, Unteroberdorster M, von Brunneck AC, Capper D, Heppner FL, Chapuy B, Janz M, Schwartz S, Konietschke F, Vajkoczy P, Korfel A, Keller U. A prospective observational study of real-world treatment and outcome in secondary CNS lymphoma. Eur J Cancer. 2024 Jan;196:113436. doi: 10.1016/j.ejca.2023.113436. Epub 2023 Nov 14.
PubMed 38008033
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT05114330
- Acronym / sponsor ID
- SZNSL-R
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 8 Jun 2011 (actual)
- Primary completion
- 8 Jun 2024 (estimated)
- Study completion
- 8 Jun 2026 (estimated)
- First posted
- 9 Nov 2021 (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.
The objective of the observation is to collect and document data on treatment strategies for secondary central nervous system lymphoma (SCNSL) in routine clinical practice, whether obtained in the context of clinical trials or outside of trials. In particular, the following questions will be specified:
- What therapeutic approaches are being pursued?
- What is the clinical outcome of the various treatment options?
- What is the frequency of serious adverse events with each therapeutic approach?
Detailed description
The observational study is to be conducted in inpatient clinics, outpatient clinics and by oncology physicians in private practice. The investigators will be invited to participate by the Charité - CNS Lymphoma Working Group (Charité AG ZNSL) or the Competence Network Malignant Lymphomas (KML). When a patient is reported, the personal data of the physician including the patient will be recorded and compiled in the form of a list documentation.
All patients with SCNSL can and should be included in the study regardless of which therapy options are used and regardless of whether it is a first-line treatment, the treatment of a recurrence or a maintenance therapy for SCNSL. No intervention is associated with the conduct of the observational study with regard to the selection and implementation of the specific therapeutic regimen, diagnostics, and examination frequency during and after treatment.
The following information should be documented:
- Patient demographics and medical history
- Tumor extent at the time of initial diagnosis and CNS involvement
- Prior therapy
- General condition
- Therapy regimen for the CNS involvement
- Response
- Adverse drug reactions
- Tolerability of therapy: acute toxicity
- Chronic therapy toxicity, especially late neurotoxicity
- Time to treatment failure (relapse or progression)
- Death from any cause
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Systemic (= localized outside the CNS) lymphoma with secondary CNS involvement at initial diagnosis |
| Cohort 2 | – | –CNS relapse of previously systemic lymphoma |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with SCNSL
Key inclusion criteria (1 listed)
- All patients with SCNSL can and should be included in the registry regardless of which treatment options are used and whether the treatment being given is first-line, recurrence, or maintenance therapy for SCNSL.
Key exclusion criteria (1 listed)
- None
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
Description of different therapeutic regimens
Time frame: Through study completion, an average of 3 years
Description of different therapeutic regimens
Outcome of different therapeutic regimens
Time frame: Through study completion, an average of 3 years
Overall Survival
Outcome of different therapeutic regimens
Time frame: Through study completion, an average of 3 years
Progression Free Survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 38008033Habringer S, Demel UM, Fietz AK, Lammer F, Schroers R, Hofer S, Bairey O, Braess J, Meier-Stiegen AS, Stuhlmann R, Schmidt-Hieber M, Hoffmann J, Zinngrebe B, Kaiser U, Reimer P, Mohle R, Fix P, Hoffkes HG, Langenkamp U, Buschenfelde CMZ, Hopfer O, Stoltefuss A, La Rosee P, Blasberg H, Jordan K, Kaun S, Meurer A, Unteroberdorster M, von Brunneck AC, Capper D, Heppner FL, Chapuy B, Janz M, Schwartz S, Konietschke F, Vajkoczy P, Korfel A, Keller U. A prospective observational study of real-world treatment and outcome in secondary CNS lymphoma. Eur J Cancer. 2024 Jan;196:113436. doi: 10.1016/j.ejca.2023.113436. Epub 2023 Nov 14.
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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. This study is not recruiting at the moment.
Stefan Habringer, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Lymphoma and Non-Hodgkin Lymphoma, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Habringer, MD (stefan.habringer@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of different therapeutic regimens (time frame: Through study completion, an average of 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05114330, which also lists 1 linked publication.
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 27 Nov 2023.