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

NCT01949129 | Recruiting Phase 2 DMC

• 1 other identifier: ALL SCTped FORUM 2012
• Study Type: interventional
• Target: 1,800
• Locations: 28 countries
• Sites: 110

Brief Summary

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

Conditions

Acute Lymphoblastic Leukaemia

Keywords

stem cell transplantation; children and adolescents; high risk acute lymphoblastic leukaemia

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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

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

Secondary Outcomes (5)

• EFS (Stratum 1a and 1b)

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

• TRM

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

• Relapse/progression

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

• Acute and late toxicity for Stratum 1a, 1b and 2

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

• OS (Stratum 2)

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

Other Outcomes (3)

• Acute Graft versus Host Disease (aGVHD)

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

• Secondary malignancies

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

• Chronic Graft-versus-host disease (cGvHD)

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

Study Arms (4)

Flu/Thio/Treo

EXPERIMENTAL

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

TBI/VP16

ACTIVE COMPARATOR

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

Flu/Thio/ivBu

EXPERIMENTAL

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

Bu/VP16/Cy

EXPERIMENTAL

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

VP16 DRUG

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

Also known as: Etoposide

Bu/VP16/Cy; TBI/VP16

TBI RADIATION

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

TBI/VP16

Thiotepa DRUG

2x5 mg/kg BW, 1 day

Also known as: Thio

Flu/Thio/Treo; Flu/Thio/ivBu

Treosulfan DRUG

14g/m² BS, 3 days

Also known as: Treo

Flu/Thio/Treo

Fludarabine DRUG

30 mg/m² BS, 5 days

Also known as: Flu

Flu/Thio/Treo; Flu/Thio/ivBu

Busulfan DRUG

iV, dosage according therapeutic drug monitoring, 4 days

Also known as: Bu

Bu/VP16/Cy; Flu/Thio/ivBu

ATG Thymoglobulin DRUG

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

Also known as: ATG Thymo

Flu/Thio/Treo; Flu/Thio/ivBu; TBI/VP16

Cyclophosphamide DRUG

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

Bu/VP16/Cy; Flu/Thio/ivBu

Grafalon DRUG

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

Also known as: Anti-human T-lymphocyte immunoglobulin

Flu/Thio/Treo; Flu/Thio/ivBu; TBI/VP16

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Anna Kinderkrebsforschung: lead
• ALL SCTped Forum: collaborator
• European Society for Blood and Marrow Transplantation: collaborator
• ALL-BFM Study Group: collaborator
• Assistance Publique - Hôpitaux de Paris: collaborator
• Dutch Childhood Oncology Group: collaborator
• Swiss Pediatric Oncology Group: collaborator
• Australian & New Zealand Children's Haematology/Oncology Group: collaborator

Study Sites (119)

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

Buenos Aires, Argentina

RECRUITING

Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit

La Plata, 1651, Argentina

RECRUITING

Children's Cancer Centre The Royal Children's Hospital

Melbourne, 3052, Australia

ACTIVE NOT RECRUITING

Princess Margaret Hospital for Children

Perth, 6008, Australia

ACTIVE NOT RECRUITING

Sydney Children's Hospital

Randwick, 2031, Australia

ACTIVE NOT RECRUITING

Lady Cilento Children's Hospital

South Brisbane, 4101, Australia

ACTIVE NOT RECRUITING

The Children's Hospital at Westmead Oncology Unit

Sydney, 2145, Australia

ACTIVE NOT RECRUITING

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

Graz, 8036, Austria

RECRUITING

Universitätsklinik für Kinder- und Jugendheilkunde

Innsbruck, 6020, Austria

RECRUITING

St. Anna Children's Hospital, Vienna, Austria

Vienna, 1090, Austria

RECRUITING

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Belarus

RECRUITING

Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)

Brussels, 1020, Belgium

RECRUITING

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

Montreal Children's Hospital

Montral, Canada

ACTIVE NOT RECRUITING

CHU Sainte-Justine Hematology-Oncology Division

Montreal, Canada

RECRUITING

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

Toronto, Canada

RECRUITING

BC Children's Hospital

Vancouver, Canada

RECRUITING

CancerCare Manitoba/University of Manitoba

Winnipeg, Canada

NOT YET RECRUITING

Hospital Dr Luis Calvo Mackenna

Santiago, Chile

RECRUITING

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

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

Copenhagen, 2100, Denmark

RECRUITING

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

Helsinki, 00029 HUS, Finland

RECRUITING

CHU Bordeaux

Bordeaux, 33076, France

ACTIVE NOT RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

ACTIVE NOT RECRUITING

CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant

Grenoble, 38043, France

ACTIVE NOT RECRUITING

CHRU Lille, Service d'Hématologie Pédiatrique

Lille, 59037, France

ACTIVE NOT RECRUITING

IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique

Lyon, 69372, France

ACTIVE NOT RECRUITING

Hopital la Timone Adulte

Marseille, 13385, France

ACTIVE NOT RECRUITING

Hopital Arnaud de Villeneuve

Montpellier, 34295, France

ACTIVE NOT RECRUITING

CHU Nancy - Hopital d'Enfants

Nancy, 54500, France

ACTIVE NOT RECRUITING

CHU Nantes, Service d'onco hémato pédiatrie

Nantes, 44093, France

ACTIVE NOT RECRUITING

Hôpital Robert Debré

Paris, 75019, France

ACTIVE NOT RECRUITING

CHU de Rennes, Serive d'Onco-Pédiatrie

Rennes, 35203, France

ACTIVE NOT RECRUITING

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

Rouen, 76031, France

ACTIVE NOT RECRUITING

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

Strasbourg, 67098, France

ACTIVE NOT RECRUITING

Uniklinik RWTH Aachen, Kinder- und Jugendmedizin

Aachen, 52074, Germany

ACTIVE NOT RECRUITING

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum

Berlin, 13353, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie

Bonn, 53113, Germany

ACTIVE NOT RECRUITING

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

Düsseldorf, 40225, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Erlangen, Kinder- und Jugendklinik

Erlangen, 1054, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Essen, Klinik für Kinderheilkunde III

Essen, 45122, Germany

ACTIVE NOT RECRUITING

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

Frankfurt am Main, 60590, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin

Freiburg im Breisgau, 79106, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin

Giessen, 35392, Germany

ACTIVE NOT RECRUITING

Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin

Greifswald, 17475, Germany

ACTIVE NOT RECRUITING

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

Halle, 06120, Germany

ACTIVE NOT RECRUITING

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

Hamburg, 20246, Germany

ACTIVE NOT RECRUITING

Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin

Hanover, 30625, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin

Heidelberg, 69120, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Jena, Sektion für Stammzelltransplantation

Jena, 07745, Germany

ACTIVE NOT RECRUITING

UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie

Kiel, 24105, Germany

ACTIVE NOT RECRUITING

Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie

Leipzig, 04103, Germany

ACTIVE NOT RECRUITING

Klinikum der Universität München, Dr. von Haunersches Kinderspital

München, 80337, Germany

ACTIVE NOT RECRUITING

Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München

München, 80804, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin

Münster, 48149, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin

Regensburg, 93053, Germany

ACTIVE NOT RECRUITING

Universitätsklinik für Kinder- und Jugendmedizin Tübingen

Tübingen, 72076, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin

Ulm, 89075, Germany

ACTIVE NOT RECRUITING

Universitäts-Kinderklinik Würzburg

Würzburg, 97080, Germany

ACTIVE NOT RECRUITING

Saint Sophia Children's Hospital BMT Unit

Athens, 11527, Greece

RECRUITING

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

Budapest, 1097, Hungary

RECRUITING

Rambam Medical Center

Haifa, 31096, Israel

RECRUITING

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

RECRUITING

Dana Children's Hospital

Tel Aviv, 64239, Israel

RECRUITING

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

Bologna, 40138, Italy

NOT YET RECRUITING

Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO

Florence, 50139, Italy

WITHDRAWN

Istituto Gaslini Genova Oncoematologia Pediatrica-

Genoa, 16147, Italy

NOT YET RECRUITING

A.O. San Gerardo di Monza Clinica Pediatrica

Monza, 20900, Italy

RECRUITING

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

Napoli, 80123, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Padova Oncoematologia Pediatrica

Padua, 35128, Italy

NOT YET RECRUITING

Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

RECRUITING

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

Pisa, 56126, Italy

NOT YET RECRUITING

Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome

Rome, 00165, Italy

RECRUITING

Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti

Torino, 10126, Italy

TERMINATED

University of Malaya, Department of Paediatrics

Kuala Lumpur, Malaysia

RECRUITING

Instituto Nacional de Peditria

Mexico City, Mexico

RECRUITING

Leiden University Medical Center Department of Pediatrics/BMT unit

Leiden, 2300, Netherlands

RECRUITING

Princess Máxima Center for Pediatric Oncology

Utrecht, 3584, Netherlands

RECRUITING

Starship Children's Hospital

Auckland, 1142, New Zealand

ACTIVE NOT RECRUITING

Oslo University Hospital Rikshospitalet

Oslo, 0424, Norway

RECRUITING

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

Bydgoszcz, Poland

RECRUITING

University Children's Hospital in Krakow, Department of Transplantation

Krakow, Poland

WITHDRAWN

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

Lublin, Poland

NOT YET RECRUITING

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

Poznan, Poland

RECRUITING

Cape of Hope, Wroclaw Medical University

Wroclaw, Poland

RECRUITING

IInsitutul Clinic Fundeni, Sectia de Transplant Medular

Bucharest, Romania

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

RECRUITING

King Abdullah specialists children hospital

Riyadh, Saudi Arabia

RECRUITING

University Children's Hospital

Bratislava, 83340, Slovakia

RECRUITING

University childrens' hospital, UMCL

Ljubljana, Slovenia

RECRUITING

Hospital Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Hospital Vall d'Hebron

Barcelona, Spain

RECRUITING

Hospital Materno Infantil de Málaga

Málaga, Spain

NOT YET RECRUITING

Hospital Virgen de la Arrixaca

Murcia, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

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

Gothenburg, 41685, Sweden

RECRUITING

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

Lund, 22185, Sweden

RECRUITING

Karolinska University Hospital, Department of Pediatrics

Stockholm, 14186, Sweden

RECRUITING

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

Uppsala, 75185, Sweden

RECRUITING

Universitäts-Kinderspital beider Basel (UKBB)

Basel, 4056, Switzerland

RECRUITING

HUG Hôpitaux Universitaire de Genève

Geneva, 1211, Switzerland

RECRUITING

Universitäts-Kinderspital Zurich

Zurich, 8032, Switzerland

RECRUITING

Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit

Ankara, 06100, Turkey (Türkiye)

RECRUITING

Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit

Ankara, Turkey (Türkiye)

RECRUITING

Gülhane Training and Research Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit

Antalya, Turkey (Türkiye)

RECRUITING

Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

Antalya, Turkey (Türkiye)

RECRUITING

Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit

Istanbul, Turkey (Türkiye)

RECRUITING

Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit

Istanbul, Turkey (Türkiye)

RECRUITING

Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit

Istanbul, Turkey (Türkiye)

RECRUITING

Medipol Mega Üniversite Hastanesi

Istanbul, Turkey (Türkiye)

RECRUITING

Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit

Izmir, Turkey (Türkiye)

RECRUITING

Ege University School of Medicine Pediatric Stem Cell Transplantation Unit

Izmir, Turkey (Türkiye)

RECRUITING

Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit

Kayseri, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Buechner J, Poetschger U, Bader P, Yesilipek MA, Pichler H, Palma J, Staciuk R, Riha P, Krivan G, Ifversen M, Gungor T, Goussetis E, Kalwak K, Toporski J, Gabriel M, Renard MM, Diaz-de-Heredia C, Matic T, Calkoen FG, Svec P, Meisel R, Balduzzi AC, Locatelli F, Peters C, Dalle JH, Stein J. Outcome of children with B-cell acute lymphoblastic leukemia with hypodiploidy or BCR::ABL1 fusion undergoing allogeneic HSCT. Blood. 2025 Nov 19:blood.2025030951. doi: 10.1182/blood.2025030951. Online ahead of print.

  PMID: 41259231 DERIVED

• 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.

  PMID: 39602342 DERIVED

• 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.

  PMID: 37738088 DERIVED

• 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.

  PMID: 33974585 DERIVED

• 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.

  PMID: 33332189 DERIVED

• 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.

  PMID: 33242441 DERIVED

• 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.

  PMID: 29189665 DERIVED

Related Links

• St. Anna Kinderkrebsforschung
• St. Anna Kinderspital
• 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

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Etoposide; Thiotepa; Acetyl-CoA C-Acyltransferase; treosulfan; fludarabine; Influenza Vaccines; Busulfan; thymoglobulin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramides; Organophosphorus Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acyltransferases; Transferases; Enzymes; Enzymes and Coenzymes; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Butylene Glycols; Glycols; Alcohols; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated

Study Officials

• 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

Central Study Contacts

Christina Peters, Prof. MD PhD

CONTACT

+43140170; christina.peters@stanna.at

Tijana Frank, MD, MScEng

CONTACT

+43140470; tijana.frank@ccri.at

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. Christina Peters

Study Record Dates

• First Submitted: September 9, 2013
• First Posted: September 24, 2013
• Study Start: April 1, 2013
• Primary Completion: June 1, 2025
• Study Completion (Estimated): April 1, 2030
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

BE (1); AR (2); CZ (1); FI (1); GR (1); AU (5); CR (1); ME (1); HU (1); PL (5); SA (1); FR (13); IL (3); DK (1); NL (2); CH (3); MY (1); ES (5); NZ (1); SL (1); CL (1); TU (12); IT (10); DE (24); CA (6); RO (2); NO (1); SE (4)