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

September 1, 2026 updated by: St. Anna Kinderkrebsforschung

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

The trial was initiated as a prospective, randomised, global study to investigate whether chemotherapy based conditioning could replace TBI in pediatric patients with acute lymphoblastic leukemia (ALL) undergoing allogeneic hematopoietic stem cell transplantation (HSCT). It was registered and approved as a prospective, randomized, controlled, open-label, international, multicenter, phase III, non-inferiority trial. Pediatric patients with acute lymphoblastic leukemia (ALL) aged ≤18 years at diagnosis and 4-21 years at HSCT in complete remission pre-HSCT, and with an HLA-compatible related (MSD) or unrelated donor (MD) were randomly assigned to myeloablative conditioning with fractionated 12 Gy TBI and etoposide versus fludarabine (Flu), thiotepa (Thio), and either busulfan (Bu) or treosulfan (Treo). The decision to use the irradiation-free conditioning or Flu/Thio/Treo or Flu/Thio/ivBu was country specific. Patients aged < 4 years received irradiation-free conditioning. Patients with a mismatched donor (MMD) were stratified according to the donor's stem cell source (cord blood, haploidentical HSCT or bone marrow/peripheral blood stem cells).

The stopping rule was applied on March 31, 2019 following a suspension of random assignment in December 2018 after the chemoconditioning was proven to be significantly inferior to TBI. As a result, TBI/VP16 conditioning remains the standard for patients older than 4 years with MSD/MD. If TBI/VP16 was not the conditioning regimen, participating centres/treating physicians could choose either Flu/Thio/iv BU or Flu/Thio/Treo based on individual patient assessment.

The MSD/MD randomised patients remain in a follow-up to explore the impact of risk factors on the incidence of Adverse Events of Special Interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort.

In MMD patients, event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members is observed.

During the trial, new questions arise, such as new chemotherapy options for no-irradiation conditioning, individualised drug dosing, influence of pharmacogenomics, immune reconstitution, influence of different levels of MRD negativity, donor factors such as MSD vs. MD, HSCT in patients younger than 4 years and in infants, differences in outcome in a non-randomised cohort, factors influencing the development of acute and chronic GvHD, and many other questions that could be analysed and investigated based on the data collected in the trial. In addition, relapse remains the major cause of treatment failure in infants and young children with high-risk ALL undergoing HSCT.

To address this, the protocol was amended (version 7.0/29 October 2022) to allow a choice of conditioning between TBI/VP16 and chemo-conditioning Flu/Thio/Treo or Flu/Thio/Bu and optionally Bu/VP16/Cy for patients aged 0-2 years.

  • TBI/VP16 remains the standard of care for patients > 4 years.
  • Patients aged 2-4 years may optionally receive the TBI/VP16 conditioning at the discretion of the treating physician to avoid acute and long-term side effects, which are more pronounced in this age group.
  • Patients <2 years of age do not receive TBI.
  • For patients who are not eligible for TBI, treating physicians may choose either Flu/Thio/ivBu or Flu/Thio/Treo as both chemo-conditioning regimens result in similar OS, EFS and NRM.
  • Patients aged 0-2 years may receive Bu/VP16/Cy at the discretion of the treating physician.

In countries that have stopped enrolling patients prior to the approval of protocol version 7.0/29 October 2022, or in countries where V7.0 was not approved at the time of the transition to the Clinical Trials Regulation, the choice of conditioning between TBI/VP16 and chemo-conditioning according to international protocol version 6.0/9 September 2019 is as follows:

  • TBI/VP16 remains the standard of care for patients > 4 years.
  • Patients <4 years of age do not receive TBI.
  • For patients aged <4 years and those ineligible for TBI, treating physicians may choose either Flu/Thio/ivBu or Flu/Thio/Treo as both chemo-conditioning regimens result in similar OS, EFS and NRM.

In EU/EEA countries that have transitioned to the Clinical Trials Regulation, a consolidated version of the protocol (v8.0, effective 1 July 2024) is in use, reflecting the common core provisions of versions 6 and 7 that have been approved in the respective Member States.

Countries that are not subject to the CTR use versions that have been approved in their respective countries.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA
        • Contact:
        • Principal Investigator:
          • Raquel Staciuk, MD PhD
      • La Plata, Argentina, 1651
        • Recruiting
        • Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit
        • Principal Investigator:
          • Sandra Formisano, MD PhD
        • Sub-Investigator:
          • Daniela Iglesias, MD PhD
        • Contact:
  • Australia
      • Melbourne, Australia, 3052
        • Active, not recruiting
        • Children's Cancer Centre The Royal Children's Hospital
      • Perth, Australia, 6008
        • Active, not recruiting
        • Princess Margaret Hospital for Children
      • Randwick, Australia, 2031
        • Active, not recruiting
        • Sydney Children's Hospital
      • South Brisbane, Australia, 4101
        • Active, not recruiting
        • Lady Cilento Children's Hospital
      • Sydney, Australia, 2145
        • Active, not recruiting
        • The Children's Hospital at Westmead Oncology Unit
  • Austria
      • Graz, Austria, 8036
        • Recruiting
        • Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie
        • Contact:
        • Principal Investigator:
          • Wolfgang Schwinger, MD PhD
        • Sub-Investigator:
          • Daniela Sperl, MD
      • Innsbruck, Austria, 6020
        • Recruiting
        • Universitätsklinik für Kinder- und Jugendheilkunde
        • Contact:
        • Principal Investigator:
          • Gabriele Kropshofer, MD PhD
        • Sub-Investigator:
          • Bernhard Meister, MD
      • Vienna, Austria, 1090
        • Recruiting
        • St. Anna Children's Hospital, Vienna, Austria
        • Contact:
        • Contact:
          • herbert.pichler@stanna.at
        • Principal Investigator:
          • Herbert Pichler, MD
        • Sub-Investigator:
          • Roswitha Lüftinger, MD
        • Sub-Investigator:
          • Elisabeth Salzer, MD
  • Belarus
      • Minsk, Belarus
        • Active, not recruiting
        • Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
  • Belgium
      • Brussels, Belgium, 1020
        • Recruiting
        • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
        • Contact:
          • Pauline Mazilier, MD
        • Principal Investigator:
          • Pauline Mazilier, MD
      • Brussels, Belgium, 1200
        • Recruiting
        • Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique
        • Contact:
        • Principal Investigator:
          • Benedicte Brichard, MD PhD
      • Ghent, Belgium, 9000
        • Recruiting
        • University Hospital Gent Pediatrische hemato-oncologie
        • Contact:
        • Principal Investigator:
          • Viktoria Bourdon, MD, PhD
      • Leuven, Belgium, 3000
        • Recruiting
        • University Hospitals Leuven Kinderhemato-oncologie
        • Contact:
        • Principal Investigator:
          • Marleen Renard, MD PhD
      • Liège, Belgium
        • Recruiting
        • Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman
        • Contact:
        • Principal Investigator:
          • Marie Françoise Dresse, MD PhD
  • Canada
      • Calgary, Canada
        • Active, not recruiting
        • Alberta Children's Hospital Division of Pediatric Oncology
      • Montral, Canada
        • Active, not recruiting
        • Montreal Children's Hospital
      • Montreal, Canada
        • Active, not recruiting
        • CHU Sainte-Justine Hematology-Oncology Division
      • Toronto, Canada
        • Completed
        • Hospital for Sick Children University of Toronto Division of Haematology/Oncology
      • Vancouver, Canada
        • Completed
        • BC Children's Hospital
      • Winnipeg, Canada
        • Withdrawn
        • CancerCare Manitoba/University of Manitoba
  • Chile
      • Santiago, Chile
        • Recruiting
        • Hospital Dr Luis Calvo Mackenna
        • Contact:
        • Principal Investigator:
          • Julia Palma, MD PhD
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • Department of Pediatrics, UHC Zagreb
        • Principal Investigator:
          • Ernest Bilic, MD PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Zrinko Salek, MD
  • Czechia
      • Prague, Czechia, 150 06
        • Recruiting
        • Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University
        • Sub-Investigator:
          • Renata Formankova, MD
        • Sub-Investigator:
          • Petra Keslova, MD
        • Contact:
        • Principal Investigator:
          • Petr Riha, MD
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet
        • Contact:
        • Principal Investigator:
          • Marianne Ifversen, MD PHD
  • Finland
      • Helsinki, Finland, 00029 HUS
        • Completed
        • Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki
  • France
      • Bordeaux, France, 33076
        • Active, not recruiting
        • CHU Bordeaux
      • Clermont-Ferrand, France, 63003
        • Active, not recruiting
        • CHU Clermont-Ferrand
      • Grenoble, France, 38043
        • Active, not recruiting
        • CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant
      • Lille, France, 59037
        • Active, not recruiting
        • CHRU Lille, Service d'Hématologie Pédiatrique
      • Lyon, France, 69372
        • Active, not recruiting
        • IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique
      • Marseille, France, 13385
        • Active, not recruiting
        • Hopital la Timone Adulte
      • Montpellier, France, 34295
        • Active, not recruiting
        • Hôpital Arnaud de Villeneuve
      • Nancy, France, 54500
        • Active, not recruiting
        • CHU Nancy - Hopital d'Enfants
      • Nantes, France, 44093
        • Active, not recruiting
        • CHU Nantes, Service d'onco hémato pédiatrie
      • Paris, France, 75019
        • Active, not recruiting
        • Hôpital Robert Debré
      • Rennes, France, 35203
        • Active, not recruiting
        • CHU de Rennes, Serive d'Onco-Pédiatrie
      • Rouen, France, 76031
        • Active, not recruiting
        • CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique
      • Strasbourg, France, 67098
        • Active, not recruiting
        • CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique
  • Germany
      • Aachen, Germany, 52074
        • Active, not recruiting
        • Uniklinik RWTH Aachen, Kinder- und Jugendmedizin
      • Berlin, Germany, 13353
        • Active, not recruiting
        • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
      • Bonn, Germany, 53113
        • Active, not recruiting
        • Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie
      • Düsseldorf, Germany, 40225
        • Active, not recruiting
        • Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie
      • Erlangen, Germany, 1054
        • Active, not recruiting
        • Universitätsklinikum Erlangen, Kinder- und Jugendklinik
      • Essen, Germany, 45122
        • Active, not recruiting
        • Universitätsklinikum Essen, Klinik für Kinderheilkunde III
      • Frankfurt am Main, Germany, 60590
        • Active, not recruiting
        • Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)
      • Freiburg im Breisgau, Germany, 79106
        • Active, not recruiting
        • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
      • Greifswald, Germany, 17475
        • Active, not recruiting
        • Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin
      • Halle, Germany, 06120
        • Active, not recruiting
        • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin
      • Hamburg, Germany, 20246
        • Active, not recruiting
        • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie
      • Hanover, Germany, 30625
        • Active, not recruiting
        • Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin
      • Heidelberg, Germany, 69120
        • Active, not recruiting
        • Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin
      • Jena, Germany, 07745
        • Active, not recruiting
        • Universitätsklinikum Jena, Sektion für Stammzelltransplantation
      • Kiel, Germany, 24105
        • Active, not recruiting
        • UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie
      • Leipzig, Germany, 04103
        • Active, not recruiting
        • Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
      • München, Germany, 80337
        • Active, not recruiting
        • Klinikum der Universität München, Dr. von Haunersches Kinderspital
      • München, Germany, 80804
        • Active, not recruiting
        • Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München
      • Münster, Germany, 48149
        • Active, not recruiting
        • Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
      • Regensburg, Germany, 93053
        • Active, not recruiting
        • Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin
      • Tübingen, Germany, 72076
        • Active, not recruiting
        • Universitätsklinik für Kinder- und Jugendmedizin Tübingen
      • Ulm, Germany, 89075
        • Active, not recruiting
        • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin
      • Würzburg, Germany, 97080
        • Active, not recruiting
        • Universitäts-Kinderklinik Würzburg
    • Gießen
      • Giessen, Gießen, Germany, 35392
        • Active, not recruiting
        • Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin
  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Saint Sophia Children's Hospital BMT Unit
        • Sub-Investigator:
          • Anna Paisiou, MD
        • Sub-Investigator:
          • Dikaia-Eleni Ionnidou, MD
        • Sub-Investigator:
          • George Vessalas, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Evgenios Goussetis, MD
  • Hungary
      • Budapest, Hungary, 1097
        • Recruiting
        • National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit
        • Contact:
        • Principal Investigator:
          • Gergely Krivan, MD PhD
        • Sub-Investigator:
          • Krisztián Kallay, MD PhD
  • Israel
      • Haifa, Israel, 31096
        • Active, not recruiting
        • Rambam Medical Center
      • Petah Tikva, Israel, 49202
        • Active, not recruiting
        • Schneider Children's Medical Center of Israel
      • Tel Aviv, Israel, 64239
        • Active, not recruiting
        • Dana Children's Hospital
  • Italy
      • Bologna, Italy, 40138
        • Withdrawn
        • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
      • Florence, Italy, 50139
        • Withdrawn
        • Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO
      • Genoa, Italy, 16147
        • Withdrawn
        • Istituto Gaslini Genova Oncoematologia Pediatrica-
      • Monza, Italy, 20900
        • Active, not recruiting
        • A.O. San Gerardo di Monza Clinica Pediatrica
      • Naples, Italy, 80123
        • Withdrawn
        • A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia
      • Padova, Italy, 35128
        • Withdrawn
        • Azienda Ospedaliera di Padova Oncoematologia Pediatrica
      • Pavia, Italy, 27100
        • Active, not recruiting
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy, 56126
        • Withdrawn
        • Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.
      • Rome, Italy, 00165
        • Active, not recruiting
        • Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome
      • Torino, Italy, 10126
        • Terminated
        • Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • University of Malaya, Department of Paediatrics
        • Contact:
        • Principal Investigator:
          • Hany Ariffin, MD PhD
  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Instituto Nacional de Peditria
        • Contact:
        • Principal Investigator:
          • Alberto Olaya Vargas, MD PhD
  • Netherlands
      • Leiden, Netherlands, 2300
        • Completed
        • Leiden University Medical Center Department of Pediatrics/BMT unit
      • Utrecht, Netherlands, 3584
  • New Zealand
      • Auckland, New Zealand, 1142
        • Active, not recruiting
        • Starship Children's Hospital
  • Norway
      • Oslo, Norway, 0424
        • Recruiting
        • Oslo University Hospital Rikshospitalet
        • Contact:
        • Principal Investigator:
          • Jochen Büchner, MD PhD
  • Poland
      • Bydgoszcz, Poland
        • Active, not recruiting
        • University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology
      • Krakow, Poland
        • Withdrawn
        • University Children's Hospital in Krakow, Department of Transplantation
      • Lublin, Poland
        • Active, not recruiting
        • Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology
      • Poznan, Poland
        • Active, not recruiting
        • Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT
      • Wroclaw, Poland
        • Active, not recruiting
        • Cape of Hope, Wroclaw Medical University
  • Romania
      • Bucharest, Romania
        • Active, not recruiting
        • IInsitutul Clinic Fundeni, Sectia de Transplant Medular
      • Timișoara, Romania
        • Completed
        • 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
  • Saudi Arabia
      • Riyadh, Saudi Arabia
        • Recruiting
        • King Abdullah specialists children hospital
        • Principal Investigator:
          • Mohammed Essa, MD PhD
        • Contact:
  • Slovakia
      • Bratislava, Slovakia, 83340
        • Recruiting
        • University Children's Hospital
        • Contact:
        • Principal Investigator:
          • Peter Svec, MD PhD
        • Sub-Investigator:
          • Dominika Tanuskova, MD
  • Slovenia
      • Ljubljana, Slovenia
        • Recruiting
        • University childrens' hospital, UMCL
        • Contact:
        • Principal Investigator:
          • Simona Avčin, MD
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Iván López Torija, MD
      • Barcelona, Spain
      • Murcia, Spain
        • Recruiting
        • Hospital Virgen de la Arrixaca
        • Contact:
        • Principal Investigator:
          • José Luis Fuster, MD
      • Málaga, Spain
        • Withdrawn
        • Hospital Materno Infantil de Málaga
      • Oviedo, Spain
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
        • Principal Investigator:
          • Pilar Palomo, MD
  • Sweden
      • Gothenburg, Sweden, 41685
        • Recruiting
        • Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)
        • Contact:
        • Principal Investigator:
          • Cecilia Langenskiöld, MD
      • Lund, Sweden, 22185
        • Recruiting
        • Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology
        • Contact:
        • Principal Investigator:
          • Dominik Turkiewicz, MD
      • Stockholm, Sweden, 14186
        • Recruiting
        • Karolinska University Hospital, Department of Pediatrics
        • Contact:
        • Principal Investigator:
          • Jacek Toporski, MD
      • Uppsala, Sweden, 75185
        • Recruiting
        • University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics
        • Contact:
        • Principal Investigator:
          • Natalja Jackman, MD PhD
  • Switzerland
      • Basel, Switzerland, 4056
        • Recruiting
        • Universitäts-Kinderspital beider Basel (UKBB)
        • Contact:
        • Principal Investigator:
          • Tamara Diesch, MD PhD
      • Geneva, Switzerland, 1211
        • Recruiting
        • HUG Hôpitaux Universitaire de Genève
        • Contact:
        • Principal Investigator:
          • Marc Ansari, MD PhD
      • Zurich, Switzerland, 8032
        • Recruiting
        • Universitäts-Kinderspital Zurich
        • Contact:
        • Principal Investigator:
          • Güngör Tayfun, MD PhD
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Active, not recruiting
        • Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Ankara, Turkey (Türkiye)
        • Active, not recruiting
        • Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Ankara, Turkey (Türkiye)
        • Active, not recruiting
        • Gulhane Training and Research Hospital
      • Antalya, Turkey (Türkiye)
        • Active, not recruiting
        • Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Antalya, Turkey (Türkiye)
        • Active, not recruiting
        • Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Istanbul, Turkey (Türkiye)
        • Active, not recruiting
        • Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit
      • Istanbul, Turkey (Türkiye)
        • Active, not recruiting
        • Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit
      • Istanbul, Turkey (Türkiye)
        • Active, not recruiting
        • Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Istanbul, Turkey (Türkiye)
        • Active, not recruiting
        • Medipol Mega Üniversite Hastanesi
      • Izmir, Turkey (Türkiye)
        • Active, not recruiting
        • Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Izmir, Turkey (Türkiye)
        • Active, not recruiting
        • Ege University School of Medicine Pediatric Stem Cell Transplantation Unit
      • Kayseri, Turkey (Türkiye)
        • Active, not recruiting
        • Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Flu/Thio/Treo

Fludarabine/Thiotepa/Treosulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:

  • MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
  • MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
  • MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Drug: Thiotepa
2x5 mg/kg BW, 1 day
Other Names:
  • Thio
Drug: Treosulfan
14g/m² BS, 3 days
Other Names:
  • Treo
Drug: Fludarabine
30 mg/m² BS, 5 days
Other Names:
  • Flu
Drug: ATG Thymoglobulin
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
Other Names:
  • ATG Thymo
Drug: Grafalon
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
Other Names:
  • Anti-human T-lymphocyte immunoglobulin
Active Comparator: TBI/VP16

TBI (Total Body Irradiation) / VP16 is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients older than 48 months with:

  • MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
  • MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
  • MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide.

Patients aged 24-48 months may optionally receive Total Body Irradiation (TBI).
Drug: ATG Thymoglobulin
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
Other Names:
  • ATG Thymo
Drug: Grafalon
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
Other Names:
  • Anti-human T-lymphocyte immunoglobulin
Radiation: TBI
2 x 2Gy/day , 3 days (total 12Gy)
Drug: VP16
60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
Other Names:
  • Etoposide
Experimental: Flu/Thio/ivBu

Fludarabine/Thiotepa/iV Busulfan is used as conditioning regimen for haematopoietic stem cell transplantation (HSCT) in patients with:

  • MSD (matched sibling donors) or MD (matched related or unrelated donors). In addition, patients undergoing MD HSCT will receive ATG Thymo- or Grafalon.
  • MMD (mismatched donors) with CB (Cord blood) or TCD (T-Cell depletion) or CD34+ selection. In addition, these patients will receive ATG Thymo- or Grafalon.
  • MMD (mismatched donors) patients receiving Post TX-Cyclophosphamide
Drug: Thiotepa
2x5 mg/kg BW, 1 day
Other Names:
  • Thio
Drug: Fludarabine
30 mg/m² BS, 5 days
Other Names:
  • Flu
Drug: ATG Thymoglobulin
MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
Other Names:
  • ATG Thymo
Drug: Grafalon
MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
Other Names:
  • Anti-human T-lymphocyte immunoglobulin
Drug: Busulfan
iV, dosage according therapeutic drug monitoring, 4 days
Other Names:
  • Bu
Drug: Cyclophosphamide
as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
Other Names:
  • Cy
Experimental: Bu/VP16/Cy
Busulfan/VP16/Cyclophosphamide is an alternative conditioning arm that may optionally be used for HSCT with MSD/MD and MMD graft in patients aged 0-24 months. Patients undergoing MD HSCT will also receive ATG Thymo- or Grafalon.
Drug: Busulfan
iV, dosage according therapeutic drug monitoring, 4 days
Other Names:
  • Bu
Drug: VP16
60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning
Other Names:
  • Etoposide
Drug: Cyclophosphamide
as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna
Other Names:
  • Cy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Stratum 1 - randomisation related question was closed in December 2018; patients are in active follow-up: To show that a non total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or a HLA matched donor (MD). The primary endpoint is the OS calculated from the date of the randomisation. Death from any cause will be considered an event.
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Event free survival (EFS) Stratum 2 (mismatched donor transplantation)
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Overall Survival (OS), Stratum 1b: MSD/MD without randomisation
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire MSD/MD cohort
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
EFS (Stratum 1a and 1b)
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
EFS calculated from date of randomization (1a) or recruitment (1b) to disease progression or relapse, secondary neoplasm and death from any cause. Patients lost to follow-up without event will be censored at the date of their last follow-up evaluation.
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
TRM
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2.
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Relapse/progression
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Cumulative Incidence of Relapse for Stratum 1a, 1b and 2.
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Acute and late toxicity for Stratum 1a, 1b and 2
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
according a preselection out of CTC3
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
OS (Stratum 2)
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
The primary endpoint is the OS calculated from the date of the recruitment . Death from any cause will be considered an event.
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acute Graft versus Host Disease (aGVHD)
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
According to the modified Seattle Glucksberg criteria
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Secondary malignancies
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Incidence, type and timepoint of occurence
first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Chronic Graft-versus-host disease (cGvHD)
Time Frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years
Chronic GVHD is diagnosed using criteria created through the NIH consensus development project
first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Anna Kinderkrebsforschung

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Assistance Publique - Hôpitaux de Paris
Australian & New Zealand Children's Haematology/Oncology Group
European Society for Blood and Marrow Transplantation
Swiss Pediatric Oncology Group
ALL SCTped Forum
ALL-BFM Study Group
Dutch Childhood Oncology Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Christina Peters, Prof. MD PhD, St. Anna Kinderspital, Vienna, Austria
  • Study Chair: Peter Bader, Prof. MD PhD, Goethe University
  • Study Chair: Franco Locatelli, Prof. MD PhD, Ospedale Pediatrico Bambino Gesù, Rome, Italy
  • Study Chair: Anita Lawitschka, Assoc. Prof. MD, St. Anna Kinderspital, Vienna, Austria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALL SCTped FORUM 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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