Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia

Sponsors

Lead Sponsor: St. Anna Kinderkrebsforschung

Collaborator: ALL SCTped Forum
European Group for Blood and Marrow Transplantation
ALL-BFM Study Group
Assistance Publique - Hôpitaux de Paris
Dutch Childhood Oncology Group
Swiss Pediatric Oncology Group
Australian and New Zealand Children's Haematology/Oncology Group

Source St. Anna Kinderkrebsforschung
Brief Summary

The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen. The stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.

Detailed Description

Acute and late side effects of TBI in combination with other chemotherapeutic are manifold to the growing organism and include severe organ dysfunction/failure due to toxicity. Although transplant associated mortality was reduced after HSCT in the last decade due to better HLA matching, infection prevention and control, the burden of late complications is still a matter of concern. Growth retardation, hormonal dysfunction, sterility and the risk of secondary cancer are the late consequences of TBI in children. However, so far no prospective study has demonstrated similar outcomes in paediatric ALL using chemo-conditioning regimen before HSCT. The reason for that is manifold: only a minority of children with ALL qualifies for allogeneic HSCT as most patients are cured with sole modern chemotherapy approaches. Those with dismal prognosis are treated in HSCT centres offering a care to patients with different diseases. Therefore it is nearly impossible to answer the complex outcome questions in single centres or even in single countries. International cooperation is essential to allow prospective investigation within comparable patient cohorts. This study aimed to explore the efficacy and efficiency of two different chemo-conditioning regimens (Flu/Thio with Treo or ivBu) in comparison to the standard conditioning regimen (TBI/VP16). All patients with an indication for HSCT, age > 4 years and a matched donor (MD) or matched sibling donor (MSD) underwent a randomisation between these two conditioning regimens. The decision if the irradiation free conditioning is Flu/Thio/Treo or Flu/Thio/ivBu was stratified by country. Patients with age < 4 years received the irradiation free conditioning. Patients with a mismatched donor were stratified according to the donor's stem cell source (cordblood, haploidentical tx or bone marrow/peripheral blood stem cells). After an interim analysis of the randomized FORUM-trial in December 2018, which showed superior OS for TBI/Etoposide with equal outcomes for Bu or Treo-containing regimen, the randomization was suspended. The reason was less relapse incidence whereas 1-year TRM was comparable in all 3 arms. The randomization was closed in March 2019 based on the results of additional analyses confirming the superiority of TBI/VP16 over chemo-conditioning. Consequently, the TBI conditioning has remained a standard for the patients older than 4 years with a MSD/MD. Use of a conditioning other than TBI/VP16 in this age group is made at the center level based on the assessment of each individual patient.

Overall Status Recruiting
Start Date April 2013
Completion Date April 2026
Primary Completion Date April 2021
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only) first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Event free survival (EFS) Stratum 2 (mismatched donor transplantation) first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Overall Survival (OS), Stratum 1b: MSD/MD without randomisation first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary Outcome
Measure Time Frame
EFS (Stratum 1a and 1b) first: 18 months after inclusion of first patient, afterwards annually up to 10 years
TRM first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Relapse/progression first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Acute and late toxicity for Stratum 1a, 1b and 2 first: 18 months after inclusion of first patient, afterwards annually up to 10 years
OS (Stratum 2) first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Enrollment 1000
Condition
Intervention

Intervention Type: Drug

Intervention Name: VP16

Description: 60 mg/kg BW,1 day

Arm Group Label: TBI/VP16

Other Name: Etoposide

Intervention Type: Radiation

Intervention Name: TBI

Description: 2 x 2Gy/day , 3 days (total 12Gy)

Arm Group Label: TBI/VP16

Intervention Type: Drug

Intervention Name: Thiotepa

Description: 2x5 mg/kg BW, 1 day

Other Name: Thio

Intervention Type: Drug

Intervention Name: Treosulfan

Description: 14g/m² BS, 3 days

Arm Group Label: Flu/Thio/Treo

Other Name: Treo

Intervention Type: Drug

Intervention Name: Fludarabine

Description: 30 mg/m² BS, 5 days

Other Name: Flu

Intervention Type: Drug

Intervention Name: Busulfan

Description: iV, dosage according therapeutic drug monitoring, 4 days

Arm Group Label: Flu/Thio/ivBu

Other Name: Bu

Intervention Type: Drug

Intervention Name: ATG Thymoglobulin

Description: MD: ATG Thymo: 2,5mg/kg BW/d 3 days.

Other Name: ATG Thymo

Intervention Type: Drug

Intervention Name: Cyclophosphamide

Description: 50mg/kg BW/d 2 days with Mesna

Arm Group Label: Flu/Thio/ivBu

Other Name: Cy

Intervention Type: Drug

Intervention Name: Grafalon

Description: MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days

Other Name: Anti-human T-lymphocyte immunoglobulin

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

Gender: All

Minimum Age: 1 Month

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Christina Peters, Prof. MD PhD

Phone: +43140170

Phone Ext.: 3106

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA | Buenos Aires, Argentina Recruiting Raquel Staciuk, MD PhD [email protected] Raquel Staciuk, MD PhD Principal Investigator
Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit | La Plata, 1651, Argentina Recruiting Alcira Fynn, MD PhD [email protected] Sandra Formisano, MD PhD Principal Investigator Daniela Iglesias, MD PhD Sub-Investigator
Children's Cancer Centre The Royal Children's Hospital | Melbourne, 3052, Australia Active, not recruiting
Princess Margaret Hospital for Children | Perth, 6008, Australia Active, not recruiting
Sydney Children's Hospital | Randwick, 2031, Australia Active, not recruiting
Lady Cilento Children's Hospital | South Brisbane, 4101, Australia Active, not recruiting
The Children's Hospital at Westmead Oncology Unit | Sydney, 2145, Australia Active, not recruiting
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie | Graz, 8036, Austria Recruiting Wolfgang Schwinger, MD PhD [email protected] Wolfgang Schwinger, MD PhD Principal Investigator Herwig Lackner, MD Sub-Investigator
Universitätsklinik für Kinder- und Jugendheilkunde | Innsbruck, 6020, Austria Recruiting Gabriele Kropshofer, MD PhD [email protected] Gabriele Kropshofer, MD PhD Principal Investigator Bernhard Meister, MD Sub-Investigator
St. Anna Children's Hospital, Vienna, Austria | Vienna, 1090, Austria Recruiting Herbert Pichler, MD [email protected] Herbert Pichler, MD Principal Investigator Roswitha Lüftinger, MD Sub-Investigator Elisabeth Salzer, MD Sub-Investigator
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology | Minsk, Belarus Recruiting Olga Aleinikova, MD PhD [email protected] Olga Aleinikova, MD PhD Principal Investigator
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF) | Brussels, 1020, Belgium Recruiting Alina Ferster, MD PhD [email protected] Alina Ferster, MD PhD Principal Investigator
Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique | Brussels, 1200, Belgium Recruiting Benedicte Brichard, MD PhD [email protected] Benedicte Brichard, MD PhD Principal Investigator
University Hospital Gent Pediatrische hemato-oncologie | Gent, 9000, Belgium Recruiting Viktoria Bourdon, MD, PhD [email protected] Viktoria Bourdon, MD, PhD Principal Investigator
University Hospitals Leuven Kinderhemato-oncologie | Leuven, 3000, Belgium Recruiting Marleen Renard, MD PhD [email protected] Marleen Renard, MD PhD Principal Investigator
Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman | Liège, Belgium Recruiting Marie Françoise Dresse, MD PhD [email protected] Marie Françoise Dresse, MD PhD Principal Investigator
Alberta Children's Hospital Division of Pediatric Oncology | Calgary, Canada Recruiting Tony Truong, MD PhD [email protected] Tony Truong, MD PhD Principal Investigator Victor Lewis, MD Sub-Investigator
Montreal Children's Hospital | Montral, Canada Recruiting David Mitchell, MD PhD [email protected] David Mitchell, MD PhD Principal Investigator
CHU Sainte-Justine Hematology-Oncology Division | Montreal, Canada Recruiting Henrique Bittencourt, MD PhD [email protected] Henrique Bittencourt, MD PhD Principal Investigator
Hospital for Sick Children University of Toronto Division of Haematology/Oncology | Toronto, Canada Recruiting Donna Wall, MD PhD [email protected] Donna Wall, MD PhD Principal Investigator
BC Children's Hospital | Vancouver, Canada Recruiting Kirk Schultz, MD PhD [email protected] Kirk Schultz, MD PhD Principal Investigator Jeffery Davis, MD Sub-Investigator
CancerCare Manitoba/University of Manitoba | Winnipeg, Canada Not yet recruiting Geoff Cuvelier, MD PhD [email protected] Geoff Cuvelier, MD PhD Principal Investigator
Hospital Dr Luis Calvo Mackenna | Santiago, Chile Recruiting Julia Palma, MD PhD [email protected] Julia Palma, MD PhD Principal Investigator
Department of Pediatrics, UHC Zagreb | Zagreb, Croatia Recruiting Ernest Bilic, MD PhD Ernest Bilic, MD PhD Principal Investigator Toni Matic, MD PhD Sub-Investigator
Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University | Prague, 150 06, Czechia Recruiting Petr Sedlacek, MD PhD [email protected] Petr Sedlacek, MD PhD Principal Investigator Petr Riha, MD Sub-Investigator Renata Formankova, MD Sub-Investigator Petra Keslova, MD Sub-Investigator Jan Stary, MD Sub-Investigator
Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet | Copenhagen, 2100, Denmark Recruiting Marianne Ifversen, MD PhD [email protected] Marianne Ifversen, MD PHD Principal Investigator Carsten Heilmann, MD Sub-Investigator
Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki | Helsinki, 00029 HUS, Finland Recruiting Kim Vettenranta, MD PhD [email protected] Kim Vettenranta, MD PhD Principal Investigator
CHU Bordeaux | Bordeaux, 33076, France Recruiting Charlotte Jubert, MD PhD [email protected] Charlotte Jubert, MD PhD Principal Investigator
CHU Clermont-Ferrand | Clermont-Ferrand, 63003, France Recruiting Justyna Kanold, MD PhD [email protected] Justyna Kanold, MD PhD Principal Investigator
CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant | Grenoble, 38043, France Recruiting Dominique Plantaz, MD PhD [email protected] Dominique Plantaz, MD PhD Principal Investigator
CHRU Lille, Service d'Hématologie Pédiatrique | Lille, 59037, France Recruiting Benedicte Bruno, MD PhD [email protected] Benedicte Bruno, MD PhD Principal Investigator
IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique | Lyon, 69372, France Recruiting Yves Bertrand, MD PhD [email protected] Yves Bertrand, MD PhD Principal Investigator
Hopital la Timone Adulte | Marseille, 13385, France Recruiting Gerard Michel, MD PhD [email protected] Gerard Michel, MD PhD Principal Investigator
Hopital Arnaud de Villeneuve | Montpellier, 34295, France Recruiting Anne Sirvent, MD PhD [email protected] Anne Sirvent, MD PhD Principal Investigator
CHU Nancy - Hopital d'Enfants | Nancy, 54500, France Recruiting Cécile Pochon, MD PhD [email protected] Cécile Pochon, MD PhD Principal Investigator
CHU Nantes, Service d'onco hémato pédiatrie | Nantes, 44093, France Recruiting Fanny Rialland, MD PhD [email protected] Fanny Rialland, MD PhD Principal Investigator
Hôpital Robert Debré | Paris, 75019, France Recruiting JH Dalle, MD PhD [email protected] Jean-Hugues Dalle, MD PhD Principal Investigator
CHU de Rennes, Serive d'Onco-Pédiatrie | Rennes, 35203, France Recruiting Virginie Gandemer, MD PhD [email protected] Virginie Gandemer, MD PhD Principal Investigator
CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique | Rouen, 76031, France Recruiting Pascale Schneider, MD PhD [email protected] Pascale Schneider, MD PhD Principal Investigator
CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique | Strasbourg, 67098, France Recruiting Catherine Paillard, MD PhD [email protected] Catherine Paillard, MD PhD Principal Investigator
Uniklinik RWTH Aachen, Kinder- und Jugendmedizin | Aachen, 52074, Germany Recruiting Udo Kontny, MD PhD [email protected] Udo Kontny, MD PhD Principal Investigator Olga Moser, MD Sub-Investigator
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum | Berlin, 13353, Germany Recruiting Jörn Kühl, MD PhD [email protected] Jörn Kühl, MD PhD Principal Investigator Hedwig Deubzer, MD PhD Sub-Investigator
Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie | Bonn, 53113, Germany Recruiting Dagmar Dilloo, MD PhD [email protected] Dagmar Dilloo, MD PhD Principal Investigator Stefan Schönberger, MD Sub-Investigator
Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie | Düsseldorf, 40225, Germany Recruiting Roland Meisel, MD PhD [email protected] Roland Meisel, MD PhD Principal Investigator Friedhelm Schuster, MD Sub-Investigator
Universitätsklinikum Erlangen, Kinder- und Jugendklinik | Erlangen, 1054, Germany Recruiting Daniel Stachel, MD PhD [email protected] Daniel Stachel, MD PhD Principal Investigator Markus Metzler, MD Sub-Investigator
Universitätsklinikum Essen, Klinik für Kinderheilkunde III | Essen, 45122, Germany Recruiting Bernhard Kremens, MD PhD [email protected] Bernhard Kremens, MD PhD Principal Investigator Oliver Basu, MD Sub-Investigator
Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM) | Frankfurt am Main, 60590, Germany Recruiting Peter Bader, MD PhD [email protected] Peter Bader, MD PhD Principal Investigator Jan Soerensen, MD PhD Sub-Investigator
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin | Freiburg, 79106, Germany Recruiting Brigitte Strahm, MD PhD [email protected] Brigitte Strahm, MD PhD Principal Investigator Charlotte Niemeyer, MD PhD Sub-Investigator
Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin | Gießen, 35392, Germany Recruiting Wilhelm Wössmann, MD PhD [email protected] Wilhelm Wössmann, MD PhD Principal Investigator Alfred Reiter, MD Sub-Investigator Holger Hauch, MD Sub-Investigator
Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin | Greifswald, 17475, Germany Recruiting Holger Lode, MD PhD [email protected] Holger Lohde, MD PhD Principal Investigator Silke Kietz, MD Sub-Investigator
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin | Halle, 06120, Germany Recruiting Toralf Bernig, MD PhD [email protected] Toralf Bernig, MD PhD Principal Investigator Caspar Kühnöl, MD Sub-Investigator
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie | Hamburg, 20246, Germany Recruiting Johanna Schrum, MD PhD [email protected] Johanna Schrum, MD PhD Principal Investigator Ingo Müller, MD PhD Sub-Investigator
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin | Hannover, 30625, Germany Recruiting Karl-Walter Sykora, MD PhD [email protected] Karl-Walter Sykora, MD PhD Principal Investigator Martin Sauer, MD PhD Sub-Investigator
Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin | Heidelberg, 69120, Germany Recruiting Johann Greil, MD PhD [email protected] Johann Greil, MD PhD Principal Investigator Joachim Kunz, MD Sub-Investigator
Universitätsklinikum Jena, Sektion für Stammzelltransplantation | Jena, 07745, Germany Recruiting Bernd Gruhn, MD PhD [email protected] Bernd Gruhn, MD PhD Principal Investigator Karim Kentouche, MD Sub-Investigator
UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie | Kiel, 24105, Germany Recruiting Gunnar Cario, MD PhD [email protected] Gunnar Cario, MD PhD Principal Investigator Alexander Claviez, MD Sub-Investigator
Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie | Leipzig, 04103, Germany Recruiting Holger Christiansen, MD PhD [email protected] Holger Christiansen, MD PhD Principal Investigator Lars Fischer, MD Sub-Investigator
Klinikum der Universität München, Dr. von Haunersches Kinderspital | München, 80337, Germany Recruiting Michael Albert, MD PhD [email protected] Michael Albert, MD PhD Principal Investigator Tobias Feuchtinger, MD PhD Sub-Investigator
Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München | München, 80804, Germany Recruiting Irene Teichert- von Lüttichau, MD PhD [email protected] Irene Teichert- von Lüttichau, MD PhD Principal Investigator Angela Wawer, MD Sub-Investigator
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin | Münster, 48149, Germany Recruiting Claudia Rössig, MD PhD [email protected] Claudia Rössig, MD PhD Principal Investigator Birgit Burkhardt, MD Sub-Investigator
Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin | Regensburg, 93053, Germany Recruiting Selim Corbacioglu, MD PhD [email protected] Selim Corbacioglu, MD PhD Principal Investigator Jürgen Föll, MD Sub-Investigator
Universitätsklinik für Kinder- und Jugendmedizin Tübingen | Tübingen, 72076, Germany Recruiting Peter Lang, MD PhD [email protected] Peter Lang, MD PhD Principal Investigator
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin | Ulm, 89075, Germany Recruiting Ansgar Schulz, MD PhD [email protected]de Ansgar Schulz, MD PhD Principal Investigator Manfred Hönig, MD PhD Sub-Investigator
Universitäts-Kinderklinik Würzburg | Würzburg, 97080, Germany Recruiting Paul-Gerhardt Schlegel, MD PhD [email protected] Paul-Gerhardt Schlegel, MD PhD Principal Investigator Matthias Eyrich, MD PhD Sub-Investigator
Saint Sophia Children's Hospital BMT Unit | Athens, 11527, Greece Recruiting Vasiliki Kitra-Roussou, MD PhD [email protected] Vasiliki Kitra-Roussou, MD PhD Principal Investigator Anna Paisiou, MD Sub-Investigator Dikaia-Eleni Ionnidou, MD Sub-Investigator George Vessalas, MD Sub-Investigator
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 Central | Budapest, 1097, Hungary Recruiting Gergely Krivan, MD PhD [email protected] Gergely Krivan, MD PhD Principal Investigator Krisztián Kallay, MD PhD Sub-Investigator
Rambam Medical Center | Haifa, 31096, Israel Recruiting Roni Gefen, MD PhD [email protected] Roni Gefen, MD PhD Principal Investigator
Schneider Children's Medical Center of Israel | Petach-Tikva, 49202, Israel Recruiting Jerry Stein, MD PhD [email protected] Jerry Stein, MD PhD Principal Investigator
Dana Children's Hospital | Tel Aviv, 64239, Israel Recruiting Ronit Elhasid, MD PhD [email protected] Ronit Elhasid, MD PhD Principal Investigator
Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna | Bologna, 40138, Italy Not yet recruiting Prete Arcangelo, MD PhD [email protected] Prete Arcangelo, MD PhD Principal Investigator
Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO | Florence, 50139, Italy Not yet recruiting Veronica Tintori, MD PhD [email protected] Veronica Tintori, MD PhD Principal Investigator
Istituto Gaslini Genova Oncoematologia Pediatrica- | Genoa, 16147, Italy Not yet recruiting Edoardo Lanino, MD PhD [email protected] Edoardo Lanino, MD PhD Principal Investigator
A.O. San Gerardo di Monza Clinica Pediatrica | Monza, 20900, Italy Recruiting Adriana Balduzzi, MD PhD [email protected] Adriana Balduzzi, MD PhD Principal Investigator
A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia | Napoli, 80123, Italy Not yet recruiting Francesco Paolo Tambaro, MD [email protected] Francesco Paolo Tambaro, MD Principal Investigator
Azienda Ospedaliera di Padova Oncoematologia Pediatrica | Padova, 35128, Italy Not yet recruiting Alessandra Biffi, MD PhD [email protected] Alessandra Biffi, MD PhD Principal Investigator
Fondazione IRCCS Policlinico San Matteo | Pavia, 27100, Italy Not yet recruiting Mario Zecca, MD PhD [email protected] Mario Zecca, MD PhD Principal Investigator
Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O. | Pisa, 56126, Italy Not yet recruiting Gabriella Casazza, MD PhD [email protected] Gabriella Casazza, MD PhD Principal Investigator
Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome | Rome, 00165, Italy Recruiting Franco Locatelli, MD PhD [email protected] Franco Locatelli, MD PhD Principal Investigator
Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti | Torino, 10126, Italy Recruiting Franca Fagioli, MD PhD [email protected] Franca Fagioli, MD PhD Principal Investigator
University of Malaya, Department of Paediatrics | Kuala Lumpur, Malaysia Recruiting Hany Ariffin, MD PhD [email protected] Hany Ariffin, MD PhD Principal Investigator
Instituto Nacional de Peditria | Ciudad de México, Mexico Recruiting Alberto Olaya Vargas, MD PhD [email protected] Alberto Olaya Vargas, MD PhD Principal Investigator
Leiden University Medical Center Department of Pediatrics/BMT unit | Leiden, 2300, Netherlands Recruiting Arjan Lankester, MD PhD Arjan Lankester, MD PhD Principal Investigator
Princess Máxima Center for Pediatric Oncology | Utrecht, 3584, Netherlands Recruiting Marc Bierings, MD PhD [email protected] Marc Bierings, MD PhD Principal Investigator
Starship Children's Hospital | Auckland, 1142, New Zealand Recruiting Lochie Teague, MD PhD [email protected] Lochie Teague, MD PhD Principal Investigator
Oslo University Hospital Rikshospitalet | Oslo, 0424, Norway Recruiting Jochen Büchner, MD PhD [email protected] Jochen Büchner, MD PhD Principal Investigator
University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology | Bydgoszcz, Poland Recruiting Mariusz Wysocki, MD PhD [email protected] Mariusz Wysocki, MD PhD Principal Investigator
University Children's Hospital in Krakow, Department of Transplantation | Kraków, Poland Not yet recruiting Jolanta Gozdzik, MD PhD [email protected] Jolanta Gozdzik, MD PhD Principal Investigator
Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology | Lublin, Poland Not yet recruiting Jerzy R. Kowalczyk, MD [email protected] Jerzy R. Kowalczyk, MD Principal Investigator
Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT | Poznań, Poland Recruiting Jacek Wachowiak, MD PhD [email protected] Jacek Wachowiak, MD PhD Principal Investigator
Cape of Hope, Wroclaw Medical University | Wrocław, Poland Recruiting Alicja Chybicka, MD PhD [email protected] Alicja Chybicka, MD PhD Principal Investigator
IInsitutul Clinic Fundeni, Sectia de Transplant Medular | Bukarest, Romania Recruiting Anca Colita, MD PhD [email protected] Anca Colita, MD PhD Principal Investigator
University of Medicine and Pharmacy V. BABES, Emergency Children's Hospital LOUIS TURCANU, III. Clinic of Pediatrics , Department of Onco-hematology and Bone Marrow Transplantation | Timişoara, Romania Recruiting Cristian Jinca, MD PhD [email protected] Cristian Jinca, MD PhD Principal Investigator
King Abdullah specialists children hospital | Riyadh, Saudi Arabia Recruiting Mohammed Essa, MD PhD [email protected] Mohammed Essa, MD PhD Principal Investigator
University Children's Hospital | Bratislava, 83340, Slovakia Recruiting Peter Svec, MD PhD [email protected] Peter Svec, MD PhD Principal Investigator Dominika Tanuskova, MD Sub-Investigator
University childrens' hospital, UMCL | Ljubljana, Slovenia Not yet recruiting Vladan Rajic, MD PhD [email protected] Vladan Rajic, MD PhD Principal Investigator
Hospital Santa Creu i Sant Pau | Barcelona, Spain Recruiting Luisa Sisini, MD [email protected] Luisa Sisini, MD Principal Investigator
Hospital Vall d'Hebron | Barcelona, Spain Recruiting Cristina Díaz de Heredia, MD [email protected] Cristina Díaz de Heredia, MD Principal Investigator
Hospital Virgen de la Arrixaca | El Palmar, Spain Not yet recruiting José Luis Fuster, MD [email protected] José Luis Fuster, MD Principal Investigator
Hospital Materno Infantil de Málaga | Málaga, Spain Not yet recruiting Antonia Pascual, MD pascualmartinez5[email protected] Antonia Pascual, MD Principal Investigator
Hospital Universitario Central de Asturias | Oviedo, Spain Not yet recruiting Pilar Palomo, MD [email protected] Pilar Palomo, MD Principal Investigator
Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322) | Göteborg, 41685, Sweden Recruiting Karin Mellgren, MD PhD [email protected] Karin Mellgren, MD PhD Principal Investigator
Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology | Lund, 22185, Sweden Recruiting Jacek Toporski, MD PhD [email protected] Jacek Toporski, MD PhD Principal Investigator
Karolinska University Hospital, Department of Pediatrics | Stockholm, 14186, Sweden Not yet recruiting Jacek Winiaarski, MD PhD [email protected] Jacek Winiarski, MD PhD Principal Investigator
University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics | Uppsala, 75185, Sweden Recruiting Natalja Jackman, MD PhD [email protected] Natalja Jackman, MD PhD Principal Investigator
Universitäts-Kinderspital beider Basel (UKBB) | Basel, 4056, Switzerland Recruiting Nicolas Von der Weid, MD PhD [email protected] Nicolas Von der Weid, MD PhD Principal Investigator
HUG Hôpitaux Universitaire de Genève | Geneva, 1211, Switzerland Recruiting Marc Ansari, MD PhD [email protected] Marc Ansari, MD PhD Principal Investigator
Universitäts-Kinderspital Zurich | Zurich, 8032, Switzerland Recruiting Güngör Tayfun, MD PhD [email protected] Güngör Tayfun, MD PhD Principal Investigator
Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit | Ankara, 06100, Turkey Recruiting Mehmet Ertem, MD PhD Mehmet Ertem, MD PhD Principal Investigator Elif Ince, MD Sub-Investigator
Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit | Ankara, Turkey Recruiting Ulker Kocak, MD PhD [email protected] Ulker Kocak, MD PhD Principal Investigator
Gülhane Training and Research Hospital | Ankara, Turkey Recruiting Orhan Gursel, MD PhD [email protected] Orhan Gursel, MD PhD Principal Investigator
Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit | Antalya, Turkey Recruiting Alphan Kupesiz, MD PhD [email protected] Alphan Kupesiz, MD PhD Principal Investigator
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit | Antalya, Turkey Recruiting Akif Yesilipek, MD PhD [email protected] Akif Yesilipek, MD PhD Principal Investigator
Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit | Istanbul, Turkey Recruiting Gulyuz Ozturk, MD PhD [email protected] Gulyuz Ozturk, MD PhD Principal Investigator Didem Atay, MD Sub-Investigator
Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit | Istanbul, Turkey Recruiting Tunc Fisgin, MD PhD [email protected] Tunc Fisgin, MD PhD Principal Investigator
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit | Istanbul, Turkey Recruiting Gulsun Karasu, MD PhD [email protected] Gulsun Karasu, MD PhD Principal Investigator Suar Kilic, MD Sub-Investigator
Medipol Mega Üniversite Hastanesi | Istanbul, Turkey Recruiting Sema Anak, MD PhD [email protected] Sema Anak, MD PhD Principal Investigator Yöntem Yaman, MD Sub-Investigator
Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit | Izmir, Turkey Recruiting Hale Oren, MD PhD [email protected] Hale Oren, MD PhD Principal Investigator Sebnem Yilmaz, MD Sub-Investigator
Ege University School of Medicine Pediatric Stem Cell Transplantation Unit | Izmir, Turkey Recruiting Savaş Kansoy, MD PhD [email protected] Savaş Kansoy, MD PhD Principal Investigator Serap Aksoylar, MD Sub-Investigator
Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit | Kayseri, Turkey Recruiting Musa Karakukcu, MD PhD [email protected] Musa Karakukcu, MD PhD Principal Investigator Ekrem Unal, MD Sub-Investigator
Location Countries

Argentina

Australia

Austria

Belarus

Belgium

Canada

Chile

Croatia

Czechia

Denmark

Finland

France

Germany

Greece

Hungary

Israel

Italy

Malaysia

Mexico

Netherlands

New Zealand

Norway

Poland

Romania

Saudi Arabia

Slovakia

Slovenia

Spain

Sweden

Switzerland

Turkey

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: St. Anna Kinderspital, Austria

Investigator Full Name: Prof. Christina Peters

Investigator Title: Univ.-Prof. Dr. Christina Peters

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Flu/Thio/Treo

Type: Experimental

Description: 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.

Label: TBI/VP16

Type: Active Comparator

Description: 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.

Label: Flu/Thio/ivBu

Type: Experimental

Description: 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.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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