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

NCT ID: NCT01949129

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2030-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 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 (cordblood, haploidentical tx 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, but the age limit for TBI/VP16-based conditioning may be optionally lowered to 2 years.The use of Flu/Thio/Treo or Flu/Thio/ivBu conditioning in this age group is made at centre level based on individual patient assessment. Alternatively, patients aged 0-2 years may receive Bu/VP16/Cy at the discretion of the treating physician.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Lymphoblastic Leukaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Thiotepa

Intervention Type DRUG

2x5 mg/kg BW, 1 day

Treosulfan

Intervention Type DRUG

14g/m² BS, 3 days

Fludarabine

Intervention Type DRUG

30 mg/m² BS, 5 days

ATG Thymoglobulin

Intervention Type DRUG

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

Grafalon

Intervention Type DRUG

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

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).

Group Type ACTIVE_COMPARATOR

VP16

Intervention Type DRUG

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

TBI

Intervention Type RADIATION

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

ATG Thymoglobulin

Intervention Type DRUG

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

Grafalon

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

Thiotepa

Intervention Type DRUG

2x5 mg/kg BW, 1 day

Fludarabine

Intervention Type DRUG

30 mg/m² BS, 5 days

Busulfan

Intervention Type DRUG

iV, dosage according therapeutic drug monitoring, 4 days

ATG Thymoglobulin

Intervention Type DRUG

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

Cyclophosphamide

Intervention Type DRUG

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

Grafalon

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

VP16

Intervention Type DRUG

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

Busulfan

Intervention Type DRUG

iV, dosage according therapeutic drug monitoring, 4 days

Cyclophosphamide

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

VP16

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

Intervention Type DRUG

TBI

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

Intervention Type RADIATION

Thiotepa

2x5 mg/kg BW, 1 day

Intervention Type DRUG

Treosulfan

14g/m² BS, 3 days

Intervention Type DRUG

Fludarabine

30 mg/m² BS, 5 days

Intervention Type DRUG

Busulfan

iV, dosage according therapeutic drug monitoring, 4 days

Intervention Type DRUG

ATG Thymoglobulin

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

Intervention Type DRUG

Cyclophosphamide

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

Intervention Type DRUG

Grafalon

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Etoposide Thio Treo Flu Bu ATG Thymo Cy Anti-human T-lymphocyte immunoglobulin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ALL SCTped Forum

OTHER

Sponsor Role collaborator

European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role collaborator

ALL-BFM Study Group

NETWORK

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

Dutch Childhood Oncology Group

OTHER

Sponsor Role collaborator

Swiss Pediatric Oncology Group

OTHER

Sponsor Role collaborator

Australian & New Zealand Children's Haematology/Oncology Group

OTHER

Sponsor Role collaborator

St. Anna Kinderkrebsforschung

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof. Christina Peters

Univ.-Prof. Dr. Christina Peters

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christina Peters, Prof. MD PhD

Role: STUDY_CHAIR

St. Anna Kinderspital, Vienna, Austria

Peter Bader, Prof. MD PhD

Role: STUDY_CHAIR

Goethe University

Franco Locatelli, Prof. MD PhD

Role: STUDY_CHAIR

Ospedale Pediatrico Bambino Gesù, Rome, Italy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit

La Plata, , Argentina

Site Status RECRUITING

Children's Cancer Centre The Royal Children's Hospital

Melbourne, , Australia

Site Status ACTIVE_NOT_RECRUITING

Princess Margaret Hospital for Children

Perth, , Australia

Site Status ACTIVE_NOT_RECRUITING

Sydney Children's Hospital

Randwick, , Australia

Site Status ACTIVE_NOT_RECRUITING

Lady Cilento Children's Hospital

South Brisbane, , Australia

Site Status ACTIVE_NOT_RECRUITING

The Children's Hospital at Westmead Oncology Unit

Sydney, , Australia

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie

Graz, , Austria

Site Status RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde

Innsbruck, , Austria

Site Status RECRUITING

St. Anna Children's Hospital, Vienna, Austria

Vienna, , Austria

Site Status RECRUITING

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, , Belarus

Site Status RECRUITING

Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

Brussels, , Belgium

Site Status RECRUITING

Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique

Brussels, , Belgium

Site Status RECRUITING

University Hospital Gent Pediatrische hemato-oncologie

Ghent, , Belgium

Site Status RECRUITING

University Hospitals Leuven Kinderhemato-oncologie

Leuven, , Belgium

Site Status RECRUITING

Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman

Liège, , Belgium

Site Status RECRUITING

Alberta Children's Hospital Division of Pediatric Oncology

Calgary, , Canada

Site Status ACTIVE_NOT_RECRUITING

Montreal Children's Hospital

Montral, , Canada

Site Status ACTIVE_NOT_RECRUITING

CHU Sainte-Justine Hematology-Oncology Division

Montreal, , Canada

Site Status RECRUITING

Hospital for Sick Children University of Toronto Division of Haematology/Oncology

Toronto, , Canada

Site Status RECRUITING

BC Children's Hospital

Vancouver, , Canada

Site Status RECRUITING

CancerCare Manitoba/University of Manitoba

Winnipeg, , Canada

Site Status NOT_YET_RECRUITING

Hospital Dr Luis Calvo Mackenna

Santiago, , Chile

Site Status RECRUITING

Department of Pediatrics, UHC Zagreb

Zagreb, , Croatia

Site Status RECRUITING

Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University

Prague, , Czechia

Site Status RECRUITING

Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki

Helsinki, , Finland

Site Status RECRUITING

CHU Bordeaux

Bordeaux, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant

Grenoble, , France

Site Status ACTIVE_NOT_RECRUITING

CHRU Lille, Service d'Hématologie Pédiatrique

Lille, , France

Site Status ACTIVE_NOT_RECRUITING

IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique

Lyon, , France

Site Status ACTIVE_NOT_RECRUITING

Hopital la Timone Adulte

Marseille, , France

Site Status ACTIVE_NOT_RECRUITING

Hopital Arnaud de Villeneuve

Montpellier, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Nancy - Hopital d'Enfants

Nancy, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Nantes, Service d'onco hémato pédiatrie

Nantes, , France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Robert Debré

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

CHU de Rennes, Serive d'Onco-Pédiatrie

Rennes, , France

Site Status ACTIVE_NOT_RECRUITING

CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique

Rouen, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique

Strasbourg, , France

Site Status ACTIVE_NOT_RECRUITING

Uniklinik RWTH Aachen, Kinder- und Jugendmedizin

Aachen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie

Bonn, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie

Düsseldorf, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Erlangen, Kinder- und Jugendklinik

Erlangen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Essen, Klinik für Kinderheilkunde III

Essen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)

Frankfurt am Main, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

Freiburg im Breisgau, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin

Giessen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin

Greifswald, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin

Halle, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie

Hamburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin

Hanover, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin

Heidelberg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Jena, Sektion für Stammzelltransplantation

Jena, , Germany

Site Status ACTIVE_NOT_RECRUITING

UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie

Kiel, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie

Leipzig, , Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum der Universität München, Dr. von Haunersches Kinderspital

München, , Germany

Site Status ACTIVE_NOT_RECRUITING

Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München

München, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin

Münster, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin

Regensburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinik für Kinder- und Jugendmedizin Tübingen

Tübingen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin

Ulm, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitäts-Kinderklinik Würzburg

Würzburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Saint Sophia Children's Hospital BMT Unit

Athens, , Greece

Site Status RECRUITING

National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit

Budapest, , Hungary

Site Status RECRUITING

Rambam Medical Center

Haifa, , Israel

Site Status RECRUITING

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Dana Children's Hospital

Tel Aviv, , Israel

Site Status RECRUITING

Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna

Bologna, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO

Florence, , Italy

Site Status WITHDRAWN

Istituto Gaslini Genova Oncoematologia Pediatrica-

Genoa, , Italy

Site Status NOT_YET_RECRUITING

A.O. San Gerardo di Monza Clinica Pediatrica

Monza, , Italy

Site Status RECRUITING

A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia

Napoli, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera di Padova Oncoematologia Pediatrica

Padua, , Italy

Site Status NOT_YET_RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status RECRUITING

Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.

Pisa, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome

Rome, , Italy

Site Status RECRUITING

Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti

Torino, , Italy

Site Status TERMINATED

University of Malaya, Department of Paediatrics

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Instituto Nacional de Peditria

Mexico City, , Mexico

Site Status RECRUITING

Leiden University Medical Center Department of Pediatrics/BMT unit

Leiden, , Netherlands

Site Status RECRUITING

Princess Máxima Center for Pediatric Oncology

Utrecht, , Netherlands

Site Status RECRUITING

Starship Children's Hospital

Auckland, , New Zealand

Site Status ACTIVE_NOT_RECRUITING

Oslo University Hospital Rikshospitalet

Oslo, , Norway

Site Status RECRUITING

University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology

Bydgoszcz, , Poland

Site Status RECRUITING

University Children's Hospital in Krakow, Department of Transplantation

Krakow, , Poland

Site Status WITHDRAWN

Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology

Lublin, , Poland

Site Status NOT_YET_RECRUITING

Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT

Poznan, , Poland

Site Status RECRUITING

Cape of Hope, Wroclaw Medical University

Wroclaw, , Poland

Site Status RECRUITING

IInsitutul Clinic Fundeni, Sectia de Transplant Medular

Bucharest, , Romania

Site Status RECRUITING

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

Site Status RECRUITING

King Abdullah specialists children hospital

Riyadh, , Saudi Arabia

Site Status RECRUITING

University Children's Hospital

Bratislava, , Slovakia

Site Status RECRUITING

University childrens' hospital, UMCL

Ljubljana, , Slovenia

Site Status RECRUITING

Hospital Santa Creu i Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Materno Infantil de Málaga

Málaga, , Spain

Site Status NOT_YET_RECRUITING

Hospital Virgen de la Arrixaca

Murcia, , Spain

Site Status RECRUITING

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status RECRUITING

Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)

Gothenburg, , Sweden

Site Status RECRUITING

Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology

Lund, , Sweden

Site Status RECRUITING

Karolinska University Hospital, Department of Pediatrics

Stockholm, , Sweden

Site Status RECRUITING

University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics

Uppsala, , Sweden

Site Status RECRUITING

Universitäts-Kinderspital beider Basel (UKBB)

Basel, , Switzerland

Site Status RECRUITING

HUG Hôpitaux Universitaire de Genève

Geneva, , Switzerland

Site Status RECRUITING

Universitäts-Kinderspital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Gülhane Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

Antalya, , Turkey (Türkiye)

Site Status RECRUITING

Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Medipol Mega Üniversite Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Ege University School of Medicine Pediatric Stem Cell Transplantation Unit

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

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 (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Christina Peters, Prof. MD PhD

Role: CONTACT

+43140170 ext. 3106

Tijana Frank, MD, MScEng

Role: CONTACT

+43140470 ext. 4755

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Raquel Staciuk, MD PhD

Role: primary

Alcira Fynn, MD PhD

Role: primary

Formisano Sandra, MD PhD

Role: backup

Wolfgang Schwinger, MD PhD

Role: primary

Gabriele Kropshofer, MD PhD

Role: primary

Herbert Pichler, MD

Role: primary

[email protected]

Role: backup

Nina Minakovskaya, MD

Role: primary

Alina Ferster, MD PhD

Role: primary

Benedicte Brichard, MD PhD

Role: primary

Viktoria Bourdon, MD, PhD

Role: primary

Marleen Renard, MD PhD

Role: primary

Marie Françoise Dresse, MD PhD

Role: primary

Henrique Bittencourt, MD PhD

Role: primary

Donna Wall, MD PhD

Role: primary

Kirk Schultz, MD PhD

Role: primary

Geoff Cuvelier, MD PhD

Role: primary

Julia Palma, MD PhD

Role: primary

Ernest Bilic, MD PhD

Role: primary

Toni Matic, MD PhD

Role: backup

Petr Sedlacek, MD PhD

Role: primary

Marianne Ifversen, MD PhD

Role: primary

Kim Vettenranta, MD PhD

Role: primary

Evgenios Goussetis, MD

Role: primary

Dikaia Eleni Ioannidou, MD

Role: backup

Gergely Krivan, MD PhD

Role: primary

Roni Gefen, MD PhD

Role: primary

Jerry Stein, MD PhD

Role: primary

Ronit Elhasid, MD PhD

Role: primary

Fraia Melchionda, MD

Role: primary

Maura Faraci, MD

Role: primary

Adriana Balduzzi, MD PhD

Role: primary

Francesco Paolo Tambaro, MD

Role: primary

Manuela Tumino, MD

Role: primary

Mario Zecca, MD PhD

Role: primary

Gabriella Casazza, MD PhD

Role: primary

Franco Locatelli, MD PhD

Role: primary

Hany Ariffin, MD PhD

Role: primary

Alberto Olaya Vargas, MD PhD

Role: primary

Arjan Lankester, MD PhD

Role: primary

Role: backup

Marc Bierings, MD PhD

Role: primary

Jochen Büchner, MD PhD

Role: primary

Mariusz Wysocki, MD PhD

Role: primary

Jerzy R. Kowalczyk, MD

Role: primary

Jacek Wachowiak, MD PhD

Role: primary

Alicja Chybicka, MD PhD

Role: primary

Anca Colita, MD PhD

Role: primary

Cristian Jinca, MD PhD

Role: primary

Mohammed Essa, MD PhD

Role: primary

Peter Svec, MD PhD

Role: primary

Simona Avčin, MD

Role: primary

Isabel Badell, MD

Role: primary

Cristina Díaz de Heredia, MD

Role: primary

Antonia Isabel Pascual, MD

Role: primary

José Luis Fuster, MD

Role: primary

Pilar Palomo, MD

Role: primary

Cecilia Langenskiöld, MD

Role: primary

Dominik Turkiewicz, MD

Role: primary

Jacek Toporski, MD

Role: primary

Natalja Jackman, MD PhD

Role: primary

Nicolas Von der Weid, MD PhD

Role: primary

Marc Ansari, MD PhD

Role: primary

Güngör Tayfun, MD PhD

Role: primary

Mehmet Ertem, MD PhD

Role: primary

Elif Ince, MD

Role: backup

Ulker Kocak, MD PhD

Role: primary

Orhan Gursel, MD PhD

Role: primary

Alphan Kupesiz, MD PhD

Role: primary

Akif Yesilipek, MD PhD

Role: primary

Gulyuz Ozturk, MD PhD

Role: primary

Tunc Fisgin, MD PhD

Role: primary

Gulsun Karasu, MD PhD

Role: primary

Sema Anak, MD PhD

Role: primary

Hale Oren, MD PhD

Role: primary

Savaş Kansoy, MD PhD

Role: primary

Musa Karakukcu, MD PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39602342 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37738088 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33974585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33332189 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33242441 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29189665 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

https://kinderkrebsforschung.at/

St. Anna Kinderkrebsforschung

https://www.stanna.at/

St. Anna Kinderspital

https://pubmed.ncbi.nlm.nih.gov/33332189/

Peters C et al. 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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ALL SCTped FORUM 2012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.