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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05114330
Other study ID # SZNSL-R
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 8, 2011
Est. completion date June 8, 2026

Study information

Verified date November 2023
Source Charite University, Berlin, Germany
Contact Stefan Habringer, MD
Email stefan.habringer@charite.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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?


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


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date June 8, 2026
Est. primary completion date June 8, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
Germany Charité - Universitätsmedizin, Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie (CBF) Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of different therapeutic regimens Description of different therapeutic regimens Through study completion, an average of 3 years
Primary Outcome of different therapeutic regimens Overall Survival Through study completion, an average of 3 years
Primary Outcome of different therapeutic regimens Progression Free Survival Through study completion, an average of 3 years
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