Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Acute Lymphoblastic Leukaemia
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukaemia focused on measuring stem cell transplantation, children and adolescents, high risk acute lymphoblastic leukaemia
Eligibility Criteria
Inclusion Criteria:
Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:
- age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years
- indication for allogeneic HSCT
- complete remission (CR) before HSCT
- 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
Exclusion Criteria:
- patients who do not fulfil the inclusion criteria
- Non Hodgkin-Lymphoma
- 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
Sites / Locations
- Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABARecruiting
- Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant UnitRecruiting
- Children's Cancer Centre The Royal Children's Hospital
- Princess Margaret Hospital for Children
- Sydney Children's Hospital
- Lady Cilento Children's Hospital
- The Children's Hospital at Westmead Oncology Unit
- Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-OnkologieRecruiting
- Universitätsklinik für Kinder- und JugendheilkundeRecruiting
- St. Anna Children's Hospital, Vienna, AustriaRecruiting
- Belarusian Research Center for Pediatric Oncology, Hematology and ImmunologyRecruiting
- Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)Recruiting
- Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatriqueRecruiting
- University Hospital Gent Pediatrische hemato-oncologieRecruiting
- University Hospitals Leuven Kinderhemato-oncologieRecruiting
- Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart TilmanRecruiting
- Alberta Children's Hospital Division of Pediatric OncologyRecruiting
- Montreal Children's HospitalRecruiting
- CHU Sainte-Justine Hematology-Oncology DivisionRecruiting
- Hospital for Sick Children University of Toronto Division of Haematology/OncologyRecruiting
- BC Children's HospitalRecruiting
- CancerCare Manitoba/University of Manitoba
- Hospital Dr Luis Calvo MackennaRecruiting
- Department of Pediatrics, UHC ZagrebRecruiting
- Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles UniversityRecruiting
- Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, RigshospitaletRecruiting
- Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of HelsinkiRecruiting
- CHU BordeauxRecruiting
- CHU Clermont-FerrandRecruiting
- CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple EnfantRecruiting
- CHRU Lille, Service d'Hématologie PédiatriqueRecruiting
- IHOP / Lyon, Service Hématologie et d'Oncologie pédiatriqueRecruiting
- Hopital la Timone AdulteRecruiting
- Hopital Arnaud de VilleneuveRecruiting
- CHU Nancy - Hopital d'EnfantsRecruiting
- CHU Nantes, Service d'onco hémato pédiatrieRecruiting
- Hôpital Robert DebréRecruiting
- CHU de Rennes, Serive d'Onco-PédiatrieRecruiting
- CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie PédiatriqueRecruiting
- CHU Strasbourg, Service d'hématologie et d'oncologie pédiatriqueRecruiting
- Uniklinik RWTH Aachen, Kinder- und JugendmedizinRecruiting
- Charité - Universitätsmedizin Berlin, Campus Virchow-KlinikumRecruiting
- Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und OnkologieRecruiting
- Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische ImmunologieRecruiting
- Universitätsklinikum Erlangen, Kinder- und JugendklinikRecruiting
- Universitätsklinikum Essen, Klinik für Kinderheilkunde IIIRecruiting
- Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)Recruiting
- Universitätsklinikum Freiburg, Zentrum für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Gießen, Zentrum für Kinder- und JugendmedizinRecruiting
- Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und OnkologieRecruiting
- Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und JugendmedizinRecruiting
- Universitätsklinikum Heidelberg, Zentrum für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Jena, Sektion für StammzelltransplantationRecruiting
- UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine PädiatrieRecruiting
- Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und HämostaseologieRecruiting
- Klinikum der Universität München, Dr. von Haunersches KinderspitalRecruiting
- Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU MünchenRecruiting
- Universitätsklinikum Münster, Klinik für Kinder- und JugendmedizinRecruiting
- Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und JugendmedizinRecruiting
- Universitätsklinik für Kinder- und Jugendmedizin TübingenRecruiting
- Universitätsklinikum Ulm, Klinik für Kinder- und JugendmedizinRecruiting
- Universitäts-Kinderklinik WürzburgRecruiting
- Saint Sophia Children's Hospital BMT UnitRecruiting
- Hospital of Southern Pest, National Insitute of Hematology and Infectious DiseaseHospital of Southern Pest, National Insitute of Hematology and Infectious Disease Pediatric Bone Marrow Transplantation Unit at CentralRecruiting
- Rambam Medical CenterRecruiting
- Schneider Children's Medical Center of IsraelRecruiting
- Dana Children's HospitalRecruiting
- Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
- Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO
- Istituto Gaslini Genova Oncoematologia Pediatrica-
- A.O. San Gerardo di Monza Clinica PediatricaRecruiting
- A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia
- Azienda Ospedaliera di Padova Oncoematologia Pediatrica
- Fondazione IRCCS Policlinico San Matteo
- Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.
- Ospedale Pediatrico Bambino Gesù, Sapienza, University of RomeRecruiting
- Ospedale Infantile Regina Margherita SC Oncoematologia e Centro TrapiantiRecruiting
- University of Malaya, Department of PaediatricsRecruiting
- Instituto Nacional de PeditriaRecruiting
- Leiden University Medical Center Department of Pediatrics/BMT unitRecruiting
- Princess Máxima Center for Pediatric OncologyRecruiting
- Starship Children's HospitalRecruiting
- Oslo University Hospital RikshospitaletRecruiting
- University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric TransplantologyRecruiting
- University Children's Hospital in Krakow, Department of Transplantation
- Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology
- Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCTRecruiting
- Cape of Hope, Wroclaw Medical UniversityRecruiting
- IInsitutul Clinic Fundeni, Sectia de Transplant MedularRecruiting
- University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow TransplantationRecruiting
- King Abdullah specialists children hospitalRecruiting
- University Children's HospitalRecruiting
- University childrens' hospital, UMCL
- Hospital Santa Creu i Sant PauRecruiting
- Hospital Vall d'HebronRecruiting
- Hospital Virgen de la Arrixaca
- Hospital Materno Infantil de Málaga
- Hospital Universitario Central de Asturias
- Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)Recruiting
- Skane University Hospital, Dept. of Pediatrics, Section for Hematology and OncologyRecruiting
- Karolinska University Hospital, Department of Pediatrics
- University Children's Hospital, Dept. of Women's & Children's Health Section for PediatricsRecruiting
- Universitäts-Kinderspital beider Basel (UKBB)Recruiting
- HUG Hôpitaux Universitaire de GenèveRecruiting
- Universitäts-Kinderspital ZurichRecruiting
- Ankara University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Gazi University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Gülhane Training and Research HospitalRecruiting
- Akdeniz University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation UnitRecruiting
- Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation UnitRecruiting
- Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Medipol Mega Üniversite HastanesiRecruiting
- Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Ege University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
- Erciyes University School of Medicine Pediatric Stem Cell Transplantation UnitRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
Flu/Thio/Treo
TBI/VP16
Flu/Thio/ivBu
Fludarabine/Thiotepa/Treosulfan is for conditioning before HSCT from MSD or MD. ATG Thymo or Grafalon is used for patients who receive stem cells from unrelated donors. Fludarabine/Thiotepa/Treosulfan with either ATG Thymo or Grafalon is also used for HSCT from MMD with in vitro T-Cell Depletion (TCD) or with CD34+ selection. Fludarabine/Thiotepa/Treosulfan with Post Tx-Cyclophosphamide is used for MMD-graft without in vitro TCD.
TBI (Total Body Irradiation) / VP16 is used for conditioning for HSCT with MSD or MD graft with patients who are older than 48 months at the time of conditioning. TBI/VP16 is also used with Post TX-Cyclophosphamide for MMD-graft without in vitro T-Cell Depletion. TBI/VP16 with either ATG Thymo or Grafalon is used for MMD-HSCT with in vitro T-Cell Depletion or with CD34+ selection.
Fludarabine/Thiotepa/iV Busulfan is used for conditioning before HSCT from MSD or MD. Fludarabine/Thiotepa/iBu with either ATG Thymo or Grafalon is also used for HSCT from MMD-HSCT with T-Cell Depletion (TCD) or haplo with CD34+ selection. Fludarabine/Thiotepa/iV Busulfan with Post Tx-Cyclophosphamide is used for MMD-graft without in vitro TCD.