Clinical trial NCT05114330: Secondary Central Nervous System Lymphoma Registry - Charité
Official title: Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Nervous System Lymphoma
Non-Hodgkin Lymphoma
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with SCNSL

Brief 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?

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

Eligibility criteria: 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

Primary outcomes:
measure: Description of different therapeutic regimens
timeFrame: Through study completion, an average of 3 years
measure: Outcome of different therapeutic regimens
timeFrame: Through study completion, an average of 3 years
measure: Outcome of different therapeutic regimens
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin, Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie (CBF)
Study officials:
References: