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Secondary Central Nervous System Lymphoma Registry - Charité

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05114330
Collaborator
(none)
300
Enrollment
1
Location
180
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-interventional, Prospective Observational Study of the Treatment Practice of CNS Involvement of Malignant Lymphoma in Routine Clinical Practice
    Actual Study Start Date :
    Jun 8, 2011
    Anticipated Primary Completion Date :
    Jun 8, 2024
    Anticipated Study Completion Date :
    Jun 8, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Systemic (= localized outside the CNS) lymphoma with secondary CNS involvement at initial diagnosis
    Cohort 2

    CNS relapse of previously systemic lymphoma

    Outcome Measures

    Primary Outcome Measures

    1. Description of different therapeutic regimens [Through study completion, an average of 3 years]

      Description of different therapeutic regimens

    2. Outcome of different therapeutic regimens [Through study completion, an average of 3 years]

      Overall Survival

    3. Outcome of different therapeutic regimens [Through study completion, an average of 3 years]

      Progression Free Survival

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Charité - Universitätsmedizin, Med. Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie (CBF) Berlin Germany 12200

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stefan Habringer, Principal Investigator, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT05114330
    Other Study ID Numbers:
    • SZNSL-R
    First Posted:
    Nov 9, 2021
    Last Update Posted:
    Nov 9, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Nov 9, 2021