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Secondary Central Nervous System Lymphoma Registry - Charité

NCT ID: NCT05114330

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-08

Study Completion Date

2026-06-08

Brief Summary

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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

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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

Conditions

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Central Nervous System Lymphoma Non-Hodgkin Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Systemic (= localized outside the CNS) lymphoma with secondary CNS involvement at initial diagnosis

No interventions assigned to this group

Cohort 2

CNS relapse of previously systemic lymphoma

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

• 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.

Exclusion Criteria

• None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Stefan Habringer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Charité - Universitätsmedizin, Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie (CBF)

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Habringer, MD

Role: CONTACT

[email protected]

Facility Contacts

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Ulrich Keller, MD, Prof.

Role: primary

[email protected]
+4930 450513447

Stefan Habringer, MD

Role: backup

[email protected]
+4930450613549

References

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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.

Reference Type DERIVED
PMID: 38008033 (View on PubMed)

Other Identifiers

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SZNSL-R

Identifier Type: -

Identifier Source: org_study_id