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RecruitingNCT01949129Updated Sep 4, 2026

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

A Phase 2/3 interventional study of VP16 and TBI in Acute Lymphoblastic Leukaemia, sponsored by St. Anna Kinderkrebsforschung. Recruiting at 119 sites in 31 countries. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-04.

Sponsored by St. Anna Kinderkrebsforschung · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
1,800
Allocation
Non-randomized
Ages
1 Month to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Acute Lymphoblastic Leukaemia

Keywords

  • stem cell transplantation
  • children and adolescents
  • high risk acute lymphoblastic leukaemia
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 1,800 is above the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

St. Anna Kinderkrebsforschung is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

  • age at diagnosis ≤ 18 years. Age at ≤ 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 " Form"
  • no pregnancy
  • no secondary
  • no previous HSCT
  • HSCT is performed in a study participating centre

Exclusion criteria

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)
  • / Lansky score \< 50%
  • subjects unwilling or unable to comply with the study procedures
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,800 participants (estimated)

Study arms

  • 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 · Drug: Treosulfan · Drug: Fludarabine · Drug: ATG Thymoglobulin · Drug: Grafalon

  • 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: VP16 · Radiation: TBI · Drug: ATG Thymoglobulin · Drug: Grafalon

  • 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 · Drug: Fludarabine · Drug: Busulfan · Drug: ATG Thymoglobulin · Drug: Cyclophosphamide · Drug: Grafalon

  • 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: VP16 · Drug: Busulfan · Drug: Cyclophosphamide

Interventions

  • DrugVP16

    60 mg/kg BW,1 day in TBI/VP16 conditioning; 40 mg/kg BW in Bu/VP16/Cy conditioning

    Also known as: Etoposide

  • RadiationTBI

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

  • DrugThiotepa

    2x5 mg/kg BW, 1 day

    Also known as: Thio

  • DrugTreosulfan

    14g/m² BS, 3 days

    Also known as: Treo

  • DrugFludarabine

    30 mg/m² BS, 5 days

    Also known as: Flu

  • DrugBusulfan

    iV, dosage according therapeutic drug monitoring, 4 days

    Also known as: Bu

  • DrugATG Thymoglobulin

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

    Also known as: ATG Thymo

  • DrugCyclophosphamide

    as part of conditioning 60 mg/kg BW 2 days or as GvHD Prophylaxis 50mg/kg BW/d 2 days with Mesna

    Also known as: Cy

  • DrugGrafalon

    Drug pages: Anti-human t-lymphocyte immunoglobulin from rabbits · Thymoglobulin

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

    Also known as: Anti-human T-lymphocyte immunoglobulin

06

What researchers measure

Primary outcomes

  1. Overall Survival (OS) Stratum 1a (randomisation TBI+ chemo-conditioning vs. chemo-conditioning only)

    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.

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  2. Event free survival (EFS) Stratum 2 (mismatched donor transplantation)

    EFS after allogeneic HSCT. EFS calculated from date of recruitment to disease progression or relapse, secondary neoplasm and death from any cause.

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  3. Overall Survival (OS), Stratum 1b: MSD/MD without randomisation

    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

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Secondary outcomes

  1. EFS (Stratum 1a and 1b)

    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.

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  2. TRM

    Cumulative Incidence of Treatment-related mortality (TRM) for Stratum 1 and 2.

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  3. Relapse/progression

    Cumulative Incidence of Relapse for Stratum 1a, 1b and 2.

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  4. Acute and late toxicity for Stratum 1a, 1b and 2

    according a preselection out of CTC3

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  5. OS (Stratum 2)

    The primary endpoint is the OS calculated from the date of the recruitment . Death from any cause will be considered an event.

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

Other outcomes

  1. Acute Graft versus Host Disease (aGVHD)

    According to the modified Seattle Glucksberg criteria

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  2. Secondary malignancies

    Incidence, type and timepoint of occurence

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

  3. Chronic Graft-versus-host disease (cGvHD)

    Chronic GVHD is diagnosed using criteria created through the NIH consensus development project

    Time frame: first: 18 months after inclusion of first patient, afterwards annually up to 10 years

07

Study locations

34 of 119 sites recruiting
  • Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA
    Buenos Aires, Argentina
    Recruiting
    • Raquel Staciuk, MD PhD · Contactrstaciuk@gmail.com
    • Raquel Staciuk, MD PhD · Principal investigator
  • Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit
    La Plata, 1651, Argentina
    Recruiting
    • Sandra Formisano, MD · Contactsandraformisano@yahoo.com.ar
    • 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

    Not enrolling at this site — choose another above.

  • Princess Margaret Hospital for Children
    Perth, 6008, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Sydney Children's Hospital
    Randwick, 2031, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Lady Cilento Children's Hospital
    South Brisbane, 4101, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Children's Hospital at Westmead Oncology Unit
    Sydney, 2145, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie
    Graz, 8036, Austria
    Recruiting
    • Wolfgang Schwinger, MD PhD · Contactwolfgang.schwinger@medunigraz.at
    • Wolfgang Schwinger, MD PhD · Principal investigator
    • Daniela Sperl, MD · Sub investigator
  • Universitätsklinik für Kinder- und Jugendheilkunde
    Innsbruck, 6020, Austria
    Recruiting
  • St. Anna Children's Hospital, Vienna, Austria
    Vienna, 1090, Austria
    Recruiting
    • Herbert Pichler, MD · Contactherbert.pichler@stanna.at
    • herbert.pichler@stanna.at · Contact
    • 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
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
    Brussels, 1020, Belgium
    Recruiting
    • Pauline Mazilier, MD · Contact
    • Pauline Mazilier, MD · Principal investigator
  • Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique
    Brussels, 1200, Belgium
    Recruiting
  • University Hospital Gent Pediatrische hemato-oncologie
    Ghent, 9000, Belgium
    Recruiting
  • University Hospitals Leuven Kinderhemato-oncologie
    Leuven, 3000, Belgium
    Recruiting
  • Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman
    Liège, Belgium
    Recruiting
  • Alberta Children's Hospital Division of Pediatric Oncology
    Calgary, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Montreal Children's Hospital
    Montral, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU Sainte-Justine Hematology-Oncology Division
    Montreal, Canada
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hospital for Sick Children University of Toronto Division of Haematology/Oncology
    Toronto, Canada
    Completed

    Not enrolling at this site — choose another above.

  • BC Children's Hospital
    Vancouver, Canada
    Completed

    Not enrolling at this site — choose another above.

  • CancerCare Manitoba/University of Manitoba
    Winnipeg, Canada
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Dr Luis Calvo Mackenna
    Santiago, Chile
    Recruiting
    • Julia Palma, MD PhD · Contactjpalmab@vtr.net
    • Julia Palma, MD PhD · Principal investigator
  • Department of Pediatrics, UHC Zagreb
    Zagreb, Croatia
    Recruiting
  • Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University
    Prague, 150 06, Czechia
    Recruiting
    • Petr Riha, MD PhD · Contactpetr.riha@fnmotol.cz
    • Petr Riha, MD · Principal investigator
    • Renata Formankova, MD · Sub investigator
    • Petra Keslova, 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 · Contactifversen@rh.regionh.dk
    • Marianne Ifversen, MD PHD · Principal investigator
  • Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki
    Helsinki, 00029 HUS, Finland
    Completed

    Not enrolling at this site — choose another above.

  • CHU Bordeaux
    Bordeaux, 33076, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63003, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant
    Grenoble, 38043, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHRU Lille, Service d'Hématologie Pédiatrique
    Lille, 59037, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique
    Lyon, 69372, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hopital la Timone Adulte
    Marseille, 13385, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hopital Arnaud de Villeneuve
    Montpellier, 34295, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU Nancy - Hopital d'Enfants
    Nancy, 54500, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU Nantes, Service d'onco hémato pédiatrie
    Nantes, 44093, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Hôpital Robert Debré
    Paris, 75019, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU de Rennes, Serive d'Onco-Pédiatrie
    Rennes, 35203, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique
    Rouen, 76031, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique
    Strasbourg, 67098, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin
    Giessen, Gießen 35392, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Uniklinik RWTH Aachen, Kinder- und Jugendmedizin
    Aachen, 52074, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
    Berlin, 13353, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie
    Bonn, 53113, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie
    Düsseldorf, 40225, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Erlangen, Kinder- und Jugendklinik
    Erlangen, 1054, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Essen, Klinik für Kinderheilkunde III
    Essen, 45122, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)
    Frankfurt am Main, 60590, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
    Freiburg im Breisgau, 79106, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin
    Greifswald, 17475, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin
    Halle, 06120, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie
    Hamburg, 20246, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin
    Hanover, 30625, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin
    Heidelberg, 69120, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Jena, Sektion für Stammzelltransplantation
    Jena, 07745, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie
    Kiel, 24105, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
    Leipzig, 04103, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Klinikum der Universität München, Dr. von Haunersches Kinderspital
    München, 80337, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München
    München, 80804, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
    Münster, 48149, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin
    Regensburg, 93053, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinik für Kinder- und Jugendmedizin Tübingen
    Tübingen, 72076, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin
    Ulm, 89075, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitäts-Kinderklinik Würzburg
    Würzburg, 97080, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Saint Sophia Children's Hospital BMT Unit
    Athens, 11527, Greece
    Recruiting
    • Evgenios Goussetis, MD · Contactevgoussetis@gmail.com
    • Dikaia Eleni Ioannidou, MD · Contactelda.ioannidou@gmail.com
    • Evgenios Goussetis, MD · Principal investigator
    • Anna Paisiou, MD · Sub investigator
    • Dikaia-Eleni Ionnidou, MD · Sub investigator
    • George Vessalas, MD · Sub investigator
  • National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit
    Budapest, 1097, Hungary
    Recruiting
    • Gergely Krivan, MD PhD · Contactkrivang@hu.inter.net
    • Gergely Krivan, MD PhD · Principal investigator
    • Krisztián Kallay, MD PhD · Sub investigator
  • Rambam Medical Center
    Haifa, 31096, Israel
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Schneider Children's Medical Center of Israel
    Petah Tikva, 49202, Israel
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dana Children's Hospital
    Tel Aviv, 64239, Israel
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
    Bologna, 40138, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO
    Florence, 50139, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • Istituto Gaslini Genova Oncoematologia Pediatrica-
    Genoa, 16147, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • A.O. San Gerardo di Monza Clinica Pediatrica
    Monza, 20900, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia
    Naples, 80123, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliera di Padova Oncoematologia Pediatrica
    Padova, 35128, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • Fondazione IRCCS Policlinico San Matteo
    Pavia, 27100, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.
    Pisa, 56126, Italy
    Withdrawn

    Not enrolling at this site — choose another above.

  • Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome
    Rome, 00165, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti
    Torino, 10126, Italy
    Terminated

    Not enrolling at this site — choose another above.

  • University of Malaya, Department of Paediatrics
    Kuala Lumpur, Malaysia
    Recruiting
    • Hany Ariffin, MD PhD · Contacthany@ummc.edu.my
    • Hany Ariffin, MD PhD · Principal investigator
  • Instituto Nacional de Peditria
    Mexico City, Mexico
    Recruiting
  • Leiden University Medical Center Department of Pediatrics/BMT unit
    Leiden, 2300, Netherlands
    Completed

    Not enrolling at this site — choose another above.

  • Princess Máxima Center for Pediatric Oncology
    Utrecht, 3584, Netherlands
    Recruiting
  • Starship Children's Hospital
    Auckland, 1142, New Zealand
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Oslo University Hospital Rikshospitalet
    Oslo, 0424, Norway
    Recruiting
    • Jochen Büchner, MD PhD · Contactjocbuc@ous-hf.no
    • Jochen Büchner, MD PhD · Principal investigator
  • University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology
    Bydgoszcz, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University Children's Hospital in Krakow, Department of Transplantation
    Krakow, Poland
    Withdrawn

    Not enrolling at this site — choose another above.

  • Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology
    Lublin, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT
    Poznan, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Cape of Hope, Wroclaw Medical University
    Wroclaw, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • IInsitutul Clinic Fundeni, Sectia de Transplant Medular
    Bucharest, Romania
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • 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
    Timișoara, Romania
    Completed

    Not enrolling at this site — choose another above.

  • King Abdullah specialists children hospital
    Riyadh, Saudi Arabia
    Recruiting
    • Mohammed Essa, MD PhD · Contactessamo@mngha.med.sa
    • Mohammed Essa, MD PhD · Principal investigator
  • University Children's Hospital
    Bratislava, 83340, Slovakia
    Recruiting
    • Peter Svec, MD PhD · Contactpeter.svec@gmail.com
    • Peter Svec, MD PhD · Principal investigator
    • Dominika Tanuskova, MD · Sub investigator
  • University childrens' hospital, UMCL
    Ljubljana, Slovenia
    Recruiting
  • Hospital Santa Creu i Sant Pau
    Barcelona, Spain
    Recruiting
    • Iván López Torija, MD · Contactilopezt@santpau.cat
    • Iván López Torija, MD · Principal investigator
  • Hospital Vall d'Hebron
    Barcelona, Spain
    Recruiting
  • Hospital Materno Infantil de Málaga
    Málaga, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Virgen de la Arrixaca
    Murcia, Spain
    Recruiting
    • José Luis Fuster, MD · Contactjosel.fuster@carm.es
    • José Luis Fuster, MD · Principal investigator
  • Hospital Universitario Central de Asturias
    Oviedo, Spain
    Recruiting

Showing the first 100 of 119 sites across 31 countries. Choose a country and city above to see the rest.

08

References and documents

Publications

  • Ben Hassine K, Gloor Y, Dupanloup I, Uppugunduri CRS, Mlakar V, Gonzales F, Gungor T, Ifversen M, Shaw PJ, Buechner J, Truong TH, Bittencourt H, Teague L, Toporski J, Sedlacek P, Poetschger U, Krajinovic M, Kalwak K, Balduzzi A, Algeri M, Bader P, Peters C, Dalle JH, Ansari M. Refining busulfan exposure enhances pediatric ALL HSCT outcomes: insights from the International FORUM study. Blood Adv. 2026 May 26;10(10):3719-3730. doi: 10.1182/bloodadvances.2025019142. PubMed 41779961 ↗
  • Buechner J, Poetschger U, Bader P, Yesilipek A, Pichler H, Palma J, Staciuk R, Riha P, Krivan G, Ifversen M, Gungor T, Goussetis E, Kalwak K, Toporski J, Gabriel M, Renard M, Diaz-de-Heredia C, Matic T, Calkoen FG, Svec P, Meisel R, Balduzzi A, Locatelli F, Peters C, Dalle JH, Stein J. Outcomes of BCP-ALL with hypodiploidy or BCR::ABL1 fusion in children undergoing allogeneic HSCT: results from the FORUM study. Blood. 2026 Mar 19;147(12):1365-1379. doi: 10.1182/blood.2025030951. PubMed 41259231 ↗
  • Greco R, Ruggeri A, McLornan DP, Snowden JA, Alexander T, Angelucci E, Averbuch D, Bazarbachi A, Hazenberg MD, Kalwak K, Kenyon M, Mekelenkamp H, Neven B, Pedrazzoli P, Peric Z, Risitano AM, Sanchez-Ortega I, Ciceri F, Sureda A. Indications for haematopoietic cell transplantation and CAR-T for haematological diseases, solid tumours and immune disorders: 2025 EBMT practice recommendations. Bone Marrow Transplant. 2025 Nov;60(11):1499-1525. doi: 10.1038/s41409-025-02701-3. Epub 2025 Sep 9. PubMed 40926035 ↗
  • Balduzzi A, Glogova E, Peters C, Sedlacek P, Dalle JH, Locatelli F, Meisel R, Burkhardt B, Buechner J, Wachowiak J, Bierings M, Staciuk R, Graphakos S, Gungor T, Yesilipek A, Svec P, Palma J, Krivan G, Diaz-de-Heredia C, Limido F, Ansari M, Kalwak K, Bader P, Ifversen M. Impact of minimal residual disease on the outcome of hematopoietic stem cell transplantation for childhood acute lymphoblastic leukemia within the FORUM trial. Haematologica. 2026 Jan 1;111(1):122-134. doi: 10.3324/haematol.2025.287456. Epub 2025 Aug 7. PubMed 40820816 ↗
  • Kalwak K, Moser LM, Potschger U, Bader P, Kleinschmidt K, Meisel R, Dalle JH, Yesilipek A, Balduzzi A, Krivan G, Goussetis E, Staciuk R, Sedlacek P, Pichler H, Svec P, Gabriel M, Gungor T, Bilic E, Buechner J, Renard M, Vettenranta K, Ifversen M, Diaz-de-Heredia C, Stein J, Toporski J, Bierings M, Peters C, Ansari M, Locatelli F. Comparable outcomes after busulfan- or treosulfan-based conditioning for allo-HSCT in children with ALL: results of FORUM. Blood Adv. 2025 Feb 25;9(4):741-751. doi: 10.1182/bloodadvances.2024014548. PubMed 39602342 ↗
  • Bader P, Potschger U, Dalle JH, Moser LM, Balduzzi A, Ansari M, Buechner J, Gungor T, Ifversen M, Krivan G, Pichler H, Renard M, Staciuk R, Sedlacek P, Stein J, Heusel JR, Truong T, Wachowiak J, Yesilipek A, Locatelli F, Peters C. Low rate of nonrelapse mortality in under-4-year-olds with ALL given chemotherapeutic conditioning for HSCT: a phase 3 FORUM study. Blood Adv. 2024 Jan 23;8(2):416-428. doi: 10.1182/bloodadvances.2023010591. PubMed 37738088 ↗
  • Gomez SM, Varela MA, Ruiz C, Sung L. Comparable Outcomes of Matched Sibling Donor and Matched Unrelated Donor Stem Cell Transplantation in Children With Acute Leukemia in Argentina. J Pediatr Hematol Oncol. 2021 Oct 1;43(7):e1020-e1024. doi: 10.1097/MPH.0000000000002174. PubMed 33974585 ↗
  • Peters C, Dalle JH, Locatelli F, Poetschger U, Sedlacek P, Buechner J, Shaw PJ, Staciuk R, Ifversen M, Pichler H, Vettenranta K, Svec P, Aleinikova O, Stein J, Gungor T, Toporski J, Truong TH, Diaz-de-Heredia C, Bierings M, Ariffin H, Essa M, Burkhardt B, Schultz K, Meisel R, Lankester A, Ansari M, Schrappe M; IBFM Study Group;; von Stackelberg A; IntReALL Study Group; Balduzzi A; I-BFM SCT Study Group; Corbacioglu S; EBMT Paediatric Diseases Working Party; Bader P. Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study. J Clin Oncol. 2021 Feb 1;39(4):295-307. doi: 10.1200/JCO.20.02529. Epub 2020 Dec 17. PubMed 33332189 ↗
  • Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available. PubMed 33242441 ↗
  • Choong E, Uppugunduri CRS, Marino D, Kuntzinger M, Doffey-Lazeyras F, Lo Piccolo R, Chalandon Y, Peters C, Daali Y, Ansari M. Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance. Ther Drug Monit. 2018 Feb;40(1):84-92. doi: 10.1097/FTD.0000000000000468. PubMed 29189665 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01949129
Lead sponsor
St. Anna Kinderkrebsforschung
Collaborators
ALL SCTped Forum, European Society for Blood and Marrow Transplantation, ALL-BFM Study Group, Assistance Publique - Hôpitaux de Paris, Dutch Childhood Oncology Group, Swiss Pediatric Oncology Group, Australian & New Zealand Children's Haematology/Oncology Group
Responsible party
Sponsor
First posted
Sep 24, 2013
Start date
Apr 2013
Primary completion
Jun 1, 2030 (estimated)
Completion
Jun 1, 2030 (estimated)
Last update
Sep 4, 2026

Study contacts

Christina Peters, Prof. MD PhD
Contact
christina.peters@stanna.at
+43140170 ext. 3106
Tijana Frank, MD, MScEng
Contact
tijana.frank@ccri.at
+43140470 ext. 4755
Christina Peters, Prof. MD PhD
study chair · St. Anna Kinderspital, Vienna, Austria
Peter Bader, Prof. MD PhD
study chair · Goethe University
Franco Locatelli, Prof. MD PhD
study chair · Ospedale Pediatrico Bambino Gesù, Rome, Italy
Anita Lawitschka, Assoc. Prof. MD
study chair · St. Anna Kinderspital, Vienna, Austria

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Etoposide · Thiotepa · Treosulfan · Fludarabine · Busulfan · Cyclophosphamide · Anti-human t-lymphocyte immunoglobulin from rabbits · Thymoglobulin

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