last updated at 22.11.2019

LCH CNS 2003

Registry and Diagnostic Guidelines for Central Nervous System Disease in Langerhans Cell Histiocytosis.

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS

Diagnose

  • Kinderonkologie und -hämatologie

Studienziel / Fragestellung

Primäres Prüfziel
  • The goals of this study are to (1) to implement a standardized diagnostic program performed at standardized intervals in patients with CNS LCH

  • (2) to to collect more information on the underlying pathological mechanism
  • and to study the disease course
  • (3) to retrospectively evaluate the efficacy of the therapeutic regimes given to registered onto the study.

Patientenmerkmale

Stadium

Histopathological Diagnosis of LCH

Alter

-199

Einschlusskriterien

Patients of

  • any age with a histopathological diagnosis of LCH according to the criteria proposed by the Histiocyte Society and
  • with evidence of CNS LCH proven by MRI will be registered and evaluated according to the diagnostic program of the study.

Studiendesign

  • Multizentrisch
  • Phase II
  • Prospektiv

Intervention


Drug: anti-thymocyte globulin; Drug: busulfan; Drug: cyclophosphamide; Drug: cyclosporine; Drug: fludarabine phosphate; Drug: melphalan; Drug: methylprednisolone; Procedure: chemotherapy; Procedure: graft versus host disease prophylaxis/therapy; Procedure: immunoglobulin therapy; Procedure: radiation therapy; Procedure: umbilical cord blood transplantation

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • GPOH (Gesellschaft für Pädiatrische Onkologie und Hämatologie)

Prüfzentrum 1

 

  • Klinik und Poliklinik für Kinder- und Jugendmedizin

Studienbüro

  • Klinisches Studienzentrum Pädiatrie

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. med. Thorsten Simon

Stellvertretender Prüfer

  • Dr. med. Dorothea Schwamborn
  • Prof. Dr. med. Matthias Fischer

Ärztliches Mitglied der Prüfgruppe

  • Dr. med. Rita Kiener
  • Dr. med. Marc Hömberg
  • Dr. med. Diana Dworaczek
  • geb. Gomez Alcazar

Studienkontakt im Prüfzentrum

  • Prof. Dr. med. Thorsten Simon

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