ALL SCT FORUM Registry 2022
Author: Julia Dobke, Last modification: 2024/04/12
https://kinderkrebsinfo.de/doi/e274309
ALL SCT FORUM Registry 2022 |
Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia |
Disease |
Children and adolescents until 21 years (age at diagnosis until 18 years or age at HSCT until 21 years) old with the diagnosis ALL in first or any following remission with high risk (HR) or very HR of recurrence of ALL |
Type |
Interim Registry |
Rationale / Objectives |
Allogene Stammzelltransplantationen bei Kindern und Jugendlichen sollten weiterhin zentral im Rahmen der FORUM-Registerstudie dokumentiert werden, bis eine Nachfolgestudie eröffnet wird.
|
Inclusion Criteria |
- Patients with ALL (except patients with mature B-ALL) who fulfil the following criteria: Indication for allogeneic SCT according to the frontline treatment consortium and
- Age at diagnosis up to 18 years or age at HSCT up to 21 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 by the parents (legal guardian) and, if necessary, by the minor patient via “Informed Consent Form”
- No pregnancy
- No secondary malignancy
- No previous HSCT
- HSCT is performed in a centre participating in the registry
- Patients with severe concomitant disease (e.g. malformation syndromes, cardiac malformations, metabolic disorders) can be included, but the intensity of conditioning regimen should be considered on an individual patient basis on the discretion of the treating physician; this can be discussed with the coordinating investigator for the respective patient.
- Patients with Karnofsky / Lansky score under 50 % can be included, but the intensity of conditioning regimen should be considered on an individual patient basis on the discretion of the treating physician; this can be discussed with the coordinating investigator for the respective patient.
|
Exclusion Criteria |
- Patients who do not fulfil the inclusion criteria
- Non Hodgkin-Lymphoma
- Severe renal impairment (GFR under 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
- Subjects unwilling or unable to comply with the study procedures
|
Status |
2023 until the start of a new trial |
Principal Investigator |
Prof. Dr. med. Peter Bader |
Contact |
Coordinating Investigator
Prof. Dr. med.
Peter Bader
Klinikum der Johann-Wolfgang-Goethe-Universität
Zentrum für Kinder- und Jugendmedizin, Klinik III
Theodor-Stern-Kai 7
60590
Frankfurt
Telefon +49 (69) 6301 7542
Fax +49 (69) 6301 6700
peter.bader@kgu.de
Study Management
Bettina Beck
Universitätsklinikum Frankfurt
Klinik für Kinder- und Jugendmedizin, Schwerpunkt Stammzelltransplantation, Immunologie und Intensivmedizin
Theodor-Stern-Kai 7
60590
Frankfurt
Telefon +49 69 6301-84269
Fax +49 69 6301-85122
bettina.beck@kgu.de
|
Participants |
German transplant centers |