ALL-SZT BFM 2003

Author: Julia Dobke, erstellt am: 2010/04/08, Last modification: 2013/01/15

Title Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukeamia (ALL)
Disease Patients with acute lymphoblastic leukeamia (ALL) and an indication for allogeneic haematopoietic stem cell transplantation (HSCT)
Type Open, multicentre, controlled, prospective study for therapy and therapy optimisation in patients with acute lymphoblastic leukeamia (ALL) and an indication for allogeneic haematopoietic stem cell transplantation (HSCT) Important: until the start of the new study, the ALL-SCT will be turned into a registry. Start of the registry: 09-2011
Problem / Objectives

Main objectives

  • To evaluate whether haematopoietic stem cell transplantation (HSCT) from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD).
  • To compare the efficacy of HSCT between mismatched family or unrelated donors (MMD) and matched donors (MSD/MD).
  • To determine whether therapy has been carried out according to the main HSCT ALL-SCT BFM protocoll recommendations.
  • The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison between survival after HSCT and survival after chemotherapy only.
  • To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.

Secondary objectives

  • To prospectively evaluate survival and event free survival after HSCT from matched sibling donors (MSD), from matched family or unrelated donors (MD) and from mismatched family or unrelated donors (MMD).
  • To reduce transplantation associated mortality by standardising the selection criteria for donors, the stem cell manipulation and supportive measures for allogeneic HSCT.
  • To prevent extensive chronic GvHD by close monitoring and by using standardised GvHD and anti-infectious therapy.
Therapy / Study arms

The stratification into the single transplantation modalities for patients in first or second remission is specified by the indication and the availibility of a donor in the single groups for transplantation. The criteria for the indication are defined by the AIEOP/ALL -BFM trial, the Interfant trial, the COALL trial and the ALL-REZ trial. The choice of the therapy regimen is determined by the chosen donor independend of the given indication. Within the donor group the conditioning will be stratified depending of the age of the patient, genetic factors [presence of t(4;11)] and the feasibility of a whole body irradiation.

Inclusion Criteria
  • Age at ALL diagnosis (for HSCT indication in first complete remission) or at ALL relapse diagnosis: ≤18 years
  • ALL in first, second or any following complete remission
  • Indication for allogeneic HSCT signed informed consent of parents or legal guardian of the minor patient (and in certain cases of the patient himself/herself) for participation in the study ALL SCT BFM 2003.
  • The patient is treated in a hospital participating in the study during the study period.
  • No pregnancy
  • No secondary malignancy
  • No history of allogeneic or autologous HSCT
  • The patient is study patient in a ALL-BFM or ALL-REZ or COALL trial
Recruitment 552 patients
Status Start:: 03.10.2003
Principal Investigator Doz. Dr. Christina Peters
E-Mail mailto:christina.peters@stanna.at
Contact

Chair

Prof. Dr. Christina Peters
St. Anna Kinderspital
Zimmermann Platz 10
A-1090 Wien
Telefon +43 (1) 40170 3100
Fax +43 (1) 40170 7430
Christina.Peters@stanna.at

Principal Investigator and coordinator ALL-BFM

Prof. Dr. med. Martin Schrappe
Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Klinik für Kinder- und Jugendmedizin I
Arnold-Heller-Str. 3
24105 Kiel
Telefon +49 (431) 500 20102
Fax +49 (431) 500 20104
m.schrappe@pediatrics.uni-kiel.de

Principal Investigator and coordinator for Germany >= CR2

PD Dr. med. Arend von Stackelberg
Charité, Campus Virchow-Klinikum
Klinik f. Pädiatrie m. S. Onkologie und Hämatologie
Augustenburger Platz 1
13353 Berlin
Telefon +49 (30) 450 566833
Fax +49 (30) 450 566901
arend.stackelberg@charite.de

Documentation SCT in 1. CR, BFM-hospitals

Melanie Gerzmehle
Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Klinik für Kinder- und Jugendmedizin I, AIEOP-BFM ALL Studienzentrale
Arnold-Heller-Straße 3
24105 Kiel
Telefon +49 (431) 500 20141
Fax +49 (431) 500 20144
Melanie.Gerzmehle@pediatrics.uni-kiel.de

Documentation ALL in >= 2. CR

Melanie Gerzmehle
Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Klinik für Kinder- und Jugendmedizin I, AIEOP-BFM ALL Studienzentrale
Arnold-Heller-Straße 3
24105 Kiel
Telefon +49 (431) 500 20141
Fax +49 (431) 500 20144
Melanie.Gerzmehle@pediatrics.uni-kiel.de

Documentation Austria and COALL-participants

Ingeborg Hirsch
St. Anna Kinderkrebsforschung e.V.
CHILDREN'S CANCER RESEARCH INSTITUTE
Zimmermannplatz 10
1090 Wien
Telefon +43 (1) 40470-4755
Fax +43 (1) 40470-7430
ingeborg.hirsch@ccri.at

Participants Germany, Austria, Switzerland
Documents
Link(s) Studienliteratur SZT