IntReAll SR 2010
Author: Julia Dobke, Last modification: 2022/07/13 https://kinderkrebsinfo.de/doi/e140835
IntReAll SR 2010 | International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010 (closed for recruitment) |
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Disease | Late isolated B-cell precursor (BCP) bone marrow (BM) relapse, late/early combined BCP BM relapse, any late/early isolated extramedullary (EM) relapse. End of recruitment: July 2020 |
Type | Intergroup, international multicentre, phase III treatment optimisation trial |
Rationale / Objectives |
Though survival of children with acute lymphoblastic leukemia (ALL) has considerably improved over the past few decades, relapsed ALL remains a leading cause of mortality in children with cancer. Given the rarity of the disease, prospective clinical trials need to be coordinated within an international cooperative group such as the International BFM Study Group (I-BFM-SG). Within the group, over the last few years two different treatment protocols, ALL-REZ BFM 2002 and ALL R3 have been used by most study groups for treatment of relapsed ALL. Both trials have produced comparable results.
Primary objevtives
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Therapy / Study arms |
Before the start of the treatment the first ramdomization into the study-arms A (ALL-REZ BFM 2002) or B (UK-ALL-R3) has to take place. After the end of the induction therapy all patient with a response (M1 or M2) to the therapy will be randomized into the study-arms "With Epratuzumab" or "Without Epratuzumab". |
Inclusion Criteria |
Inclusion criteria specific for the epratuzumab randomization
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Exclusion Criteria |
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Recruitment | 600 |
Status | June 2014 to July 2020 |
EudraCT | 2012-000793-30 |
Entry Study Register | |
Principal Investigator | Dr. med Arend v. Stackelberg |
allrez@charite.de | |
URL | http://www.intreall-fp7.eu/ |
Contact |
Principal InvestigatorPD 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 Trial CoordinationDr. Christiane Chen-Santel Charité, Campus Virchow-Klinikum Klinik für Pädiatrie m. S. Onkologie und Hämatologie Augustenburger Platz 1 13353 Berlin Telefon +49 (251) 83 52833 christiane.chen-santel@charite.de Andrej Lissat Charité - Universitätsmedizin Berlin Pädiatrische klinik m. S. Onkologie/ Hämatologie, ALL-REZ Studien Augustenburger Platz 1 13353 Berlin Telefon +49 (30) 450 566 074 Fax +49 (30) 450 566 901 andrej.lissat@charite.de Study centre GermanyAndrea Kretschmann Charité, Campus Virchow-Klinikum ALL-REZ Studienzentrale, Klinik für Pädiatrie m.S.Onkologie und Hämatologie Augustenburger Platz 1 13353 Berlin Telefon +49 (30) 450 566 354 Fax +49 (30) 450 566 901 andrea.kretschmann@charite.de Julia Dobke Charité Universitätsmedizin Berlin Pädiatrische Klinik m. S. Onkologie, Hämatologie und SZT Augustenburger Platz 1 13353 Berlin Telefon +49 (30) 450 566 354 Fax +49 (30) 450 566 901 julia.dobke@charite.de Reference laboratory Cytomorphology and MRDCornelia Eckert Charité, Campus Virchow-Klinikum Klinik für Pädiatrie m.S. Onkologie/Hämatologie, José-Carreras-Tagesklinik Augustenburger Platz 1 13353 Berlin Telefon +49 (30) 450 666088 / 450 566116 Fax +49 (30) 450 566946 cornelia.eckert@charite.de Reference laboratory ImmunophenotypingCornelia Eckert Charité, Campus Virchow-Klinikum Klinik für Pädiatrie m.S. Onkologie/Hämatologie, José-Carreras-Tagesklinik Augustenburger Platz 1 13353 Berlin Telefon +49 (30) 450 666088 / 450 566116 Fax +49 (30) 450 566946 cornelia.eckert@charite.de |
Participants | Coordinating PI: A von Stackelberg, Berlin / Germany; Co-chair: V Saha, Manchester / UK, T Revesz, Australia, G Mann, Vienna / Austria, A. Ferster, Brussels / Belgium, L Sramkova, Prague / Czechia, T Frandsen, Copenhagen / Denmark, P Lähteenmäki, Turku / Finland, P Rohrlich, Besancon / France, O Smith, Dublin / Ireland, R. Elhasid, Tel Aviv / Israel, F Locatelli, Rome / Italy, C Ogawa, Tokyo / Japan, P Hoogerbrugge, Nijmegen / Netherlands, M Hellebostad, Oslo / Norway, E Gorczynska, Wroclaw/ Poland, J Duarte, Lisbon / Portugal, S Soderhall, Stockholm / Sweden, JP Bourquin, Zurich / Switzerland, D Bonney, Manchester / UK |
Weitere Informationen | Sponsor: Charité - Universitätsmedizin Berlin Campus Virchow Klinikum Augustenburger Platz 1 13353 Berlin |
Link(s) | Studienliteratur ALL-Rezidive |
Sponsoring | EU-FP7, Deutsche Kinderkrebsstiftung |