Outcomes of BCP-ALL with hypodiploidy or BCR::ABL1 fusion in children undergoing allogeneic HSCT: results from the FORUM study.
Jochen Buechner, Ulrike Poetschger, Peter Bader...
https://pubmed.ncbi.nlm.nih.gov/41259231Actively Recruiting
Phase 2
Phase 3
Age: 1Month - 18Years
All Genders
ID01949129
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Led by St. Anna Kinderkrebsforschung · Updated on 2024-01-16
1800
Participants Needed
119
Research Sites
252 weeks
Total Duration
On this page
Sponsors
S
St. Anna Kinderkrebsforschung
Lead Sponsor
A
ALL SCTped Forum
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children and adolescents with acute lymphoblastic leukemia (ALL) who are in complete remission and require allogeneic hematopoietic stem cell transplantation (HSCT). This multinational phase III trial aims to optimize therapy by comparing chemotherapy-based conditioning regimens to total body irradiation (TBI) combined with chemotherapy. The study focuses on evaluating overall survival and event-free survival, considering the risks of late side effects like organ dysfunction, growth issues, hormonal problems, and secondary cancers from TBI. Participants receive one of several conditioning regimens before HSCT. These include TBI with etoposide (VP16) for patients older than 4 years, or chemotherapy combinations such as fludarabine, thiotepa, treosulfan, intravenous busulfan, or busulfan with VP16 and cyclophosphamide, depending on age and donor compatibility. Some patients receive additional medications like ATG Thymoglobulin or Grafalon. The study also stratifies patients by donor type, including matched sibling, matched unrelated, and mismatched donors, to assess outcomes across these groups. During the study, participants undergo regular follow-up for up to 10 years to monitor overall survival, event-free survival, relapse, toxicity, and transplant-related mortality. Data are collected annually starting 18 months after the first patient enrollment. The trial includes assessments of acute and late side effects, with ongoing observation to understand the long-term impact of different conditioning regimens in pediatric ALL patients undergoing HSCT.
CONDITIONS
Brief Title
Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
Who Can Participate
Age: 1Month - 18Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with acute lymphoblastic leukemia (ALL) except B-ALL
- Age at diagnosis 18 years or younger; age at stem cell transplant 21 years or younger
- Indication for allogeneic hematopoietic stem cell transplantation (HSCT)
- Complete remission before HSCT
- Written consent from parents or legal guardians and minor patients if applicable
- Not pregnant
- No secondary malignancy
- No previous hematopoietic stem cell transplant
- HSCT performed at a participating study center
You will not qualify if you...
- Patients who do not meet all inclusion criteria
- Diagnosis of Non-Hodgkin Lymphoma
- Decline of protocol participation by patient or legal guardian
- No consent for saving and use of anonymous medical data for study purposes
- Severe other diseases preventing protocol treatment (e.g., malformation syndromes, cardiac malformations, metabolic disorders)
- Karnofsky or Lansky performance score below 50%
- Inability or unwillingness to comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Conditioning lasts several days before transplantation, exact duration depends on regimen used
Participants receive conditioning regimens prior to allogeneic hematopoietic stem cell transplantation (HSCT) including chemotherapy drugs and/or total body irradiation depending on age and donor type.
1 hospitalization period including conditioning and HSCT
Follow-up
Duration - Up to 10 years with annual assessments after first 18 months
Participants are followed after transplantation to monitor overall survival, event-free survival, and occurrence of acute and late side effects including organ dysfunction, growth and hormonal issues, and secondary cancers.
Annual visits after initial post-transplant period, starting 18 months after treatment
Trial Site Locations
Total: 119 locations
1
Hospital de Pediatria "Juan P. Garrahan" Combate de Los Pozos N°1800 CABA
Buenos Aires, Argentina
Actively Recruiting
2
Hospital Sor Maria Ludovica, Department Hematology Stem Cell Transplant Unit
La Plata, Argentina, 1651
Actively Recruiting
3
Children's Cancer Centre The Royal Children's Hospital
Melbourne, Australia, 3052
Active, Not Recruiting
4
Princess Margaret Hospital for Children
Perth, Australia, 6008
Active, Not Recruiting
5
Sydney Children's Hospital
Randwick, Australia, 2031
Active, Not Recruiting
6
Lady Cilento Children's Hospital
South Brisbane, Australia, 4101
Active, Not Recruiting
7
The Children's Hospital at Westmead Oncology Unit
Sydney, Australia, 2145
Active, Not Recruiting
8
Universitätsklinik für Kinder- und Jugendheilkunde, Abt. f. Hämato-Onkologie
Graz, Austria, 8036
Actively Recruiting
9
Universitätsklinik für Kinder- und Jugendheilkunde
Innsbruck, Austria, 6020
Actively Recruiting
10
St. Anna Children's Hospital, Vienna, Austria
Vienna, Austria, 1090
Actively Recruiting
11
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Belarus
Actively Recruiting
12
Hôpital Universitaire des Enfants Reine Fabiola (HUDERF)
Brussels, Belgium, 1020
Actively Recruiting
13
Cliniques Universitaires Saint-Luc (UCL) Hématologie et oncologie pédiatrique
Brussels, Belgium, 1200
Actively Recruiting
14
University Hospital Gent Pediatrische hemato-oncologie
Ghent, Belgium, 9000
Actively Recruiting
15
University Hospitals Leuven Kinderhemato-oncologie
Leuven, Belgium, 3000
Actively Recruiting
16
Centre Hospitalier Universitaire de Liège Domaine Universitaire du Sart Tilman
Liège, Belgium
Actively Recruiting
17
Alberta Children's Hospital Division of Pediatric Oncology
Calgary, Canada
Active, Not Recruiting
18
Montreal Children's Hospital
Montral, Canada
Active, Not Recruiting
19
CHU Sainte-Justine Hematology-Oncology Division
Montreal, Canada
Actively Recruiting
20
Hospital for Sick Children University of Toronto Division of Haematology/Oncology
Toronto, Canada
Actively Recruiting
21
BC Children's Hospital
Vancouver, Canada
Actively Recruiting
22
CancerCare Manitoba/University of Manitoba
Winnipeg, Canada
Not Yet Recruiting
23
Hospital Dr Luis Calvo Mackenna
Santiago, Chile
Actively Recruiting
24
Department of Pediatrics, UHC Zagreb
Zagreb, Croatia
Actively Recruiting
25
Department of Pediatric Hematology and Oncology Teaching Hospital Motol, 2nd Medical School, Charles University
Prague, Czechia, 150 06
Actively Recruiting
26
Paediatric Stem Cell Transplant and Immune Deficiency, Dept. for children and adolescents 4072, Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
27
Division of Hematology-Oncology and Stem Cell Transplantation, Hospital for Children and Adolescents, Univ. of Helsinki
Helsinki, Finland, 00029 HUS
Actively Recruiting
28
CHU Bordeaux
Bordeaux, France, 33076
Active, Not Recruiting
29
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Active, Not Recruiting
30
CHU Grenoble - Clinique Universitaire de Pédiatrie, Hôpital Couple Enfant
Grenoble, France, 38043
Active, Not Recruiting
31
CHRU Lille, Service d'Hématologie Pédiatrique
Lille, France, 59037
Active, Not Recruiting
32
IHOP / Lyon, Service Hématologie et d'Oncologie pédiatrique
Lyon, France, 69372
Active, Not Recruiting
33
Hopital la Timone Adulte
Marseille, France, 13385
Active, Not Recruiting
34
Hopital Arnaud de Villeneuve
Montpellier, France, 34295
Active, Not Recruiting
35
CHU Nancy - Hopital d'Enfants
Nancy, France, 54500
Active, Not Recruiting
36
CHU Nantes, Service d'onco hémato pédiatrie
Nantes, France, 44093
Active, Not Recruiting
37
Hôpital Robert Debré
Paris, France, 75019
Active, Not Recruiting
38
CHU de Rennes, Serive d'Onco-Pédiatrie
Rennes, France, 35203
Active, Not Recruiting
39
CHU de Rouen, Hopital des Enfants, Service d' Immuno-Hématologie Oncologie Pédiatrique
Rouen, France, 76031
Active, Not Recruiting
40
CHU Strasbourg, Service d'hématologie et d'oncologie pédiatrique
Strasbourg, France, 67098
Active, Not Recruiting
41
Uniklinik RWTH Aachen, Kinder- und Jugendmedizin
Aachen, Germany, 52074
Active, Not Recruiting
42
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum
Berlin, Germany, 13353
Active, Not Recruiting
43
Universitätsklinikum Bonn, Abteilung für Pädiatrische Hämatologie und Onkologie
Bonn, Germany, 53113
Active, Not Recruiting
44
Universitätsklinikum Düsseldorf, Klinik für Kinder-Onkologie, -Hämatologie und Klinische Immunologie
Düsseldorf, Germany, 40225
Active, Not Recruiting
45
Universitätsklinikum Erlangen, Kinder- und Jugendklinik
Erlangen, Germany, 1054
Active, Not Recruiting
46
Universitätsklinikum Essen, Klinik für Kinderheilkunde III
Essen, Germany, 45122
Active, Not Recruiting
47
Klinikum der Johann Wolfgang Goethe-Universität, Klinik für Kinder- und Jugendmedizin (KKJM)
Frankfurt am Main, Germany, 60590
Active, Not Recruiting
48
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
Freiburg im Breisgau, Germany, 79106
Active, Not Recruiting
49
Universitätsklinikum Gießen, Zentrum für Kinder- und Jugendmedizin
Giessen, Germany, 35392
Active, Not Recruiting
50
Universitätsmedizin Greifswald, Klinik und Poliklinik für Kinder- und Jugendmedizin
Greifswald, Germany, 17475
Active, Not Recruiting
51
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Kinder- und Jugendmedizin
Halle, Germany, 06120
Active, Not Recruiting
52
Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Pädiatrische Hämatologie und Onkologie
Hamburg, Germany, 20246
Active, Not Recruiting
53
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde und Jugendmedizin
Hanover, Germany, 30625
Active, Not Recruiting
54
Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin
Heidelberg, Germany, 69120
Active, Not Recruiting
55
Universitätsklinikum Jena, Sektion für Stammzelltransplantation
Jena, Germany, 07745
Active, Not Recruiting
56
UKSH - Universitätsklinikum Schleswig-Holstein, Klinik für Allgemeine Pädiatrie
Kiel, Germany, 24105
Active, Not Recruiting
57
Universitätsmedizin Leipzig, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
Leipzig, Germany, 04103
Active, Not Recruiting
58
Klinikum der Universität München, Dr. von Haunersches Kinderspital
München, Germany, 80337
Active, Not Recruiting
59
Städt. Krankenhaus München Schwabing, Universitätskinderklinik der TU München
München, Germany, 80804
Active, Not Recruiting
60
Universitätsklinikum Münster, Klinik für Kinder- und Jugendmedizin
Münster, Germany, 48149
Active, Not Recruiting
61
Universitätsklinikum Regensburg, Klinik und Poliklinik für Kinder- und Jugendmedizin
Regensburg, Germany, 93053
Active, Not Recruiting
62
Universitätsklinik für Kinder- und Jugendmedizin Tübingen
Tübingen, Germany, 72076
Active, Not Recruiting
63
Universitätsklinikum Ulm, Klinik für Kinder- und Jugendmedizin
Ulm, Germany, 89075
Active, Not Recruiting
64
Universitäts-Kinderklinik Würzburg
Würzburg, Germany, 97080
Active, Not Recruiting
65
Saint Sophia Children's Hospital BMT Unit
Athens, Greece, 11527
Actively Recruiting
66
National Institute of Haematology and Infectious Disease, Hospital of Southern Pest, Paediatric Bone Marrow Transplantation Unit
Budapest, Hungary, 1097
Actively Recruiting
67
Rambam Medical Center
Haifa, Israel, 31096
Actively Recruiting
68
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
Actively Recruiting
69
Dana Children's Hospital
Tel Aviv, Israel, 64239
Actively Recruiting
70
Azienda Ospedaliero-Universitaria Policlinico S. Orsola-Malpighi di Bologna
Bologna, Italy, 40138
Not Yet Recruiting
71
Ospedale Mayer di Firenze SODc Tumori Pediatrici e TMO
Florence, Italy, 50139
Withdrawn
72
Istituto Gaslini Genova Oncoematologia Pediatrica-
Genoa, Italy, 16147
Not Yet Recruiting
73
A.O. San Gerardo di Monza Clinica Pediatrica
Monza, Italy, 20900
Actively Recruiting
74
A.O.R.N. Santobono Pausilipon, Dipartimento di Oncoematologia
Naples, Italy, 80123
Not Yet Recruiting
75
Azienda Ospedaliera di Padova Oncoematologia Pediatrica
Padova, Italy, 35128
Not Yet Recruiting
76
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy, 27100
Actively Recruiting
77
Azienda Ospedaliero Universitaria Pisana U.O. di Oncoematologia Pediatrica A.O.
Pisa, Italy, 56126
Not Yet Recruiting
78
Ospedale Pediatrico Bambino Gesù, Sapienza, University of Rome
Rome, Italy, 00165
Actively Recruiting
79
Ospedale Infantile Regina Margherita SC Oncoematologia e Centro Trapianti
Torino, Italy, 10126
Terminated
80
University of Malaya, Department of Paediatrics
Kuala Lumpur, Malaysia
Actively Recruiting
81
Instituto Nacional de Peditria
Mexico City, Mexico
Actively Recruiting
82
Leiden University Medical Center Department of Pediatrics/BMT unit
Leiden, Netherlands, 2300
Actively Recruiting
83
Princess Máxima Center for Pediatric Oncology
Utrecht, Netherlands, 3584
Actively Recruiting
84
Starship Children's Hospital
Auckland, New Zealand, 1142
Active, Not Recruiting
85
Oslo University Hospital Rikshospitalet
Oslo, Norway, 0424
Actively Recruiting
86
University Hospital No.1, Collegium Medicum UMK, department of Paediatrics, Oncology, Hematology and Paediatric Transplantology
Bydgoszcz, Poland
Actively Recruiting
87
University Children's Hospital in Krakow, Department of Transplantation
Krakow, Poland
Withdrawn
88
Children's University Hospital, Dept. Pediatric Hematology, Oncology, and Transplantology
Lublin, Poland
Not Yet Recruiting
89
Poznan University of Medical Sciences, Department of Pediatric Onology, Hematology & HSCT
Poznan, Poland
Actively Recruiting
90
Cape of Hope, Wroclaw Medical University
Wroclaw, Poland
Actively Recruiting
91
IInsitutul Clinic Fundeni, Sectia de Transplant Medular
Bucharest, Romania
Actively Recruiting
92
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
Actively Recruiting
93
King Abdullah specialists children hospital
Riyadh, Saudi Arabia
Actively Recruiting
94
University Children's Hospital
Bratislava, Slovakia, 83340
Actively Recruiting
95
University childrens' hospital, UMCL
Ljubljana, Slovenia
Actively Recruiting
96
Hospital Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
97
Hospital Vall d'Hebron
Barcelona, Spain
Actively Recruiting
98
Hospital Materno Infantil de Málaga
Málaga, Spain
Not Yet Recruiting
99
Hospital Virgen de la Arrixaca
Murcia, Spain
Actively Recruiting
100
Hospital Universitario Central de Asturias
Oviedo, Spain
Actively Recruiting
101
Queen Silvia Children's Hospital, Department of Pediatric Oncology (Avdelnig 321-322)
Gothenburg, Sweden, 41685
Actively Recruiting
102
Skane University Hospital, Dept. of Pediatrics, Section for Hematology and Oncology
Lund, Sweden, 22185
Actively Recruiting
103
Karolinska University Hospital, Department of Pediatrics
Stockholm, Sweden, 14186
Actively Recruiting
104
University Children's Hospital, Dept. of Women's & Children's Health Section for Pediatrics
Uppsala, Sweden, 75185
Actively Recruiting
105
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Switzerland, 4056
Actively Recruiting
106
HUG Hôpitaux Universitaire de Genève
Geneva, Switzerland, 1211
Actively Recruiting
107
Universitäts-Kinderspital Zurich
Zurich, Switzerland, 8032
Actively Recruiting
108
Ankara University School of Medicine Pediatric Stem Cell Transplantation Unit
Ankara, Turkey (Türkiye), 06100
Actively Recruiting
109
Gazi University School of Medicine Pediatric Stem Cell Transplantation Unit
Ankara, Turkey (Türkiye)
Actively Recruiting
110
Gülhane Training and Research Hospital
Ankara, Turkey (Türkiye)
Actively Recruiting
111
Akdeniz University School of Medicine Pediatric Stem Cell Transplantation Unit
Antalya, Turkey (Türkiye)
Actively Recruiting
112
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
Antalya, Turkey (Türkiye)
Actively Recruiting
113
Acibadem University Atakent Hospital Pediatric Stem Cell Transplantation Unit
Istanbul, Turkey (Türkiye)
Actively Recruiting
114
Bahcelievler Medicalpark Hospital Pediatric Stem Cell Transplantation Unit
Istanbul, Turkey (Türkiye)
Actively Recruiting
115
Bahcesehir University School of Medicine Pediatric Stem Cell Transplantation Unit
Istanbul, Turkey (Türkiye)
Actively Recruiting
116
Medipol Mega Üniversite Hastanesi
Istanbul, Turkey (Türkiye)
Actively Recruiting
117
Dokuzeylul University School of Medicine Pediatric Stem Cell Transplantation Unit
Izmir, Turkey (Türkiye)
Actively Recruiting
118
Ege University School of Medicine Pediatric Stem Cell Transplantation Unit
Izmir, Turkey (Türkiye)
Actively Recruiting
119
Erciyes University School of Medicine Pediatric Stem Cell Transplantation Unit
Kayseri, Turkey (Türkiye)
Actively Recruiting
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Research Team
C
Christina Peters, Prof. MD PhD
T
Tijana Frank, MD, MScEng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Comparable outcomes after busulfan- or treosulfan-based conditioning for allo-HSCT in children with ALL: results of FORUM.
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Peter Bader, Ulrike Pötschger, Jean-Hugues Dalle...
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Sergio M Gómez, Marcela A Varela, Claudia Ruiz...
https://pubmed.ncbi.nlm.nih.gov/33974585Total Body Irradiation or Chemotherapy Conditioning in Childhood ALL: A Multinational, Randomized, Noninferiority Phase III Study.
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https://pubmed.ncbi.nlm.nih.gov/33332189Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia?
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https://pubmed.ncbi.nlm.nih.gov/33242441Therapeutic Drug Monitoring of Busulfan for the Management of Pediatric Patients: Cross-Validation of Methods and Long-Term Performance.
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https://pubmed.ncbi.nlm.nih.gov/29189665