last updated at 18.08.2019

ALL SCTped 2012 FORUM

Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukaemia

 Open, randomised, multicentre, controlled, prospective phase III study for therapy and therapy optimisation in patients with acute lymphoblastic leukaemia (ALL) and an indication for allogeneic haematopoietic stem cell transplantation (HSCT)

Status: Aktiv

ISRCTN EudraCT Clinicaltrials.gov DRKS
2012-003032-22 NCT01949129

Diagnose

  • Akute Leukämien

Studienziel / Fragestellung

Primäres Prüfziel
  • Stratum 1: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD).

    Stratum 2: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD)

  • mismatched cord blood or HLA haplo-identical family members with non TBI-conditioning regimen.

Patientenmerkmale

Alter

-18

Ausschlusskriterien

     

  • Patients who do not fulfil the inclusion criteria

  • Non Hodgkin-Lymphoma

  • ALL with extramedullary involvement with indication for TBI

  • Trisomy 21

  • Severe renal impairment (GFR<30% predicted for age)

  • Severe liver insufficiency

  • Pregnancy

  • The whole protocol or essential parts are declined either by patient  himself/herself or the respective legal Guardian

  • No consent is given for saving and propagation of anonymous medical data for study reasons

  • Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)

  • Karnofsky / Lansky score < 50%

  • Subjects unwilling or unable to comply with the study procedures

  • CNS involvement at screening timepoint

  •  

Einschlusskriterien

     

  • age at time of conditioning screening less than 18 years

  • indication for allogeneic HSCT according to the national frontline protocols (Germany: AIEOP-BFM ALL 2009, IntReALL SR 2010, Interfant 2006, CoALL and ALL REZ BFM 2002)
  • complete remission (CR) before SCT

  • written consent of the parents (legal guardian) and, if necessary,

  • the minor patient via "Informed Consent Form"

  • no pregnancy

  • no secondary malignancy

  • no previous HSCT

  • HSCT is performed in a study participating centre

  •  

Studiendesign

  • Phase III

Intervention

Intravenous Busulfan - Busilfex® (BU)

Fludarabine (FLU)

Etopophos (VP16)

Treosulfan (TREO)

Thiotepa (THIO)

ATG Fresenius S (ATG)

ATG Thymoglobulin (Thymo)

Alemtuzumab (Campath)

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • St. Anna Kinderkrebsforschung Wien

Prüfzentrum 1

 

  • Klinik für Kinder- und Jugendmedizin

Prüfer (Hauptprüfer im Zentrum)

Prof. Dr. med. Udo Kontny

Prüfzentrum 2

 

  • Zentrum für Kinderheilkunde

Studienbüro

  • Pädiatrische Hämatologie/Onkologie

Prüfer (Hauptprüfer im Zentrum)

Dr. med. Stefan Schönberger

Stellvertretender Prüfer

  • Dr. med. Carola Weber

Ärztliches Mitglied der Prüfgruppe

  • Dr. med. Gabriele Calaminus

Studienkontakt im Prüfzentrum

  • Prof. Dr. med. Dagmar Dilloo

Prüfzentrum 3

 

  • Klinik für Kinder-Onkologie
  • -Hämatolgie und Immunologie

Studienbüro

  • Klinik für Kinder-Onkologie
  • -Hämatolgie und Immunologie
  • Institut für Diagnostische und Interventionelle Radiologie

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