Actively Recruiting
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Led by Martin Schrappe · Updated on 2025-04-06
5000
Participants Needed
115
Research Sites
521 weeks
Total Duration
On this page
Sponsors
M
Martin Schrappe
Lead Sponsor
D
Deutsche Krebshilfe e.V., Bonn (Germany)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The understanding of acute lymphoblastic leukemia (ALL) in childhood and adolescence has largely changed due to extensive genetic research in recent years: ALL is now considered to be a very heterogeneous disease group. The leukemia cells present themselves with quite differently activated regulatory mechanisms of the malignant phenotype. The introduction of more accurate methods of assessing therapy response ("minimal residual disease \[MRD\] tests") has provided new insights into very different mechanisms of action, including factors influenced by host factors; this has had practical clinical consequences for the use of more individualized therapy. Multimodal therapies have enabled a cure level of over 80% for ALL in this age group. However, the own and international study data show that the therapy toxicity of the contemporary chemotherapy concepts has become unacceptably high, in particular with respect to those intensified therapies used for the treatment of patients at high risk of ALL relapse. The AIEOP-BFM ALL 2017 study therefore aims for an innovative integrated approach that will not only adapt the risk stratification to new prognostic markers using more comprehensive diagnostics, but above all, qualitatively reorient the therapy. The most important consequence will be that this study is testing immunotherapy with the bispecific antibody blinatumomab as an alternative to particularly intensive and toxic chemotherapy elements in precursor B-cell ALL (pB-ALL) patients with detectable chemotherapy resistance and at high risk of relapse. With the aim to complement the effects of the conventional chemotherapy, Blinatumomab is in addition tested in the large group of pB-ALL patients at intermediate relapse risk with seemingly unremarkable leukemia, but who account for a large proportion of all relapses. Targeted therapy is also used in the form of the proteasome inhibitor bortezomib for patients with pB-ALL and slow response to the drugs of the induction chemotherapy with the aim to overcome intrinsic chemotherapy resistance of the ALL cells. In patients with T-lineage ALL, who have particularly poor chances for cure after relapse, the established consolidation chemotherapy has proved to be particularly effective. This chemotherapy phase is therefore tested in a longer and more intensive form in such T-ALL patients with intermediate or slow early treatment response with the aim to reduce the relapses rate in this subgroup.
CONDITIONS
Official Title
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute lymphoblastic leukemia or newly diagnosed mixed phenotype acute leukemia with dominant T or B lineage or reasonable rationale for ALL-based therapy
- Newly diagnosed acute undifferentiated leukemia
- Age under 18 years (up to 17 years and 365 days) at diagnosis
- Patient enrolled at a participating center
- Written informed consent provided for trial participation and data processing
You will not qualify if you...
- Philadelphia chromosome-positive (Ph+) ALL
- Bilineal leukemia with lymphoblastic and a separate non-lymphoblastic blast subset (≥10% of total cells)
- Prior treatment with cytostatic drugs
- Glucocorticoid pre-treatment ≥1 mg/kg/day for more than two weeks during the last month before diagnosis
- Treatment started according to another protocol
- Underlying disease preventing protocol treatment (e.g., severe congenital heart disease, Charcot-Marie Syndrome, Ataxia-teleangiectasia)
- ALL diagnosed as second malignancy with prior chemotherapy or radiotherapy
- Evidence of pregnancy or lactation
- Sexually active adolescents unwilling to use highly effective contraception until 12 months after therapy
- Participation in another clinical trial except approved supportive care add-on trials
- Live vaccine immunization within 2 weeks before starting protocol treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 115 locations
1
Sydney Children's Hospital
Sydney, Australia
Actively Recruiting
2
The Children's Hospital at Westmead
Westmead, Australia
Actively Recruiting
3
Univ.Klinik für Kinder- und Jugendheilkunde Graz
Graz, Austria
Actively Recruiting
4
Univ.Klinik für Kinder- und Jugendheilkunde Innsbruck
Innsbruck, Austria
Actively Recruiting
5
Kepler Universitätsklinikum
Linz, Austria
Actively Recruiting
6
LKH Salzburg
Salzburg, Austria
Actively Recruiting
7
St. Anna Kinderspital
Vienna, Austria
Actively Recruiting
8
University Hospital Brno
Brno, Czechia
Actively Recruiting
9
Regional Hospital České Budějovice
České Budějovice, Czechia
Actively Recruiting
10
University Hospital Hradec Králové
Hradec Králové, Czechia
Actively Recruiting
11
University Hospital Olomouc
Olomouc, Czechia
Actively Recruiting
12
University Hospital Ostrava-Poruba
Ostrava-Poruba, Czechia
Actively Recruiting
13
University Hospital Plzeň
Pilsen, Czechia
Actively Recruiting
14
University Hospital Motol
Prague, Czechia
Actively Recruiting
15
Masaryk´s Hospital Ústí nad Labem
Ústí nad Labem, Czechia
Actively Recruiting
16
Kinderklinik der med. Fakultät der RWTH, Bereich Hämatologie/Onkologie
Aachen, Germany, 52074
Actively Recruiting
17
I. Klinik für Kinder u. Jugendliche, Klinikum Augsburg, Hämatologie/ Onkologie
Augsburg, Germany, 86156
Actively Recruiting
18
Klinikum Berlin-Buch II. Kinderklinik, Bereich Onkologie/Allg. Pädiatrie
Berlin, Germany, 13125
Actively Recruiting
19
Kinderklinik der Charité, Campus Virchow Klinikum (CVK), Abt.: Kinderhämatologie
Berlin, Germany, 13353
Actively Recruiting
20
Städtisches Krankenhaus, Kinderklinik
Braunschweig, Germany, 38118
Actively Recruiting
21
Klinikum Chemnitz gGmbH, Klinik für Kinder- und Jugendmedizin, Hämatologie / Onkologie
Chemnitz, Germany, 09009
Actively Recruiting
22
Kliniken der Stadt Köln GmbH, Kinderkrankenhaus Riehl
Cologne, Germany, 50735
Actively Recruiting
23
Med. Einrichtungen der Universität zu Köln, Klinik für Allg. Kinderheilkunde, Onkologisch-hämatologische Station
Cologne, Germany, 50937
Actively Recruiting
24
Carl-Thiem-Klinikum, Kinderklinik, Abt. Hämatologie/Onkologie
Cottbus, Germany, 03048
Actively Recruiting
25
Vestische Kinder- u. Jugendklinik, Universitätsklinik Witten/Herdecke
Datteln, Germany, 45711
Actively Recruiting
26
Klinikum Dortmund, Klinik f. Kinder- und Jugendmedizin
Dortmund, Germany, 44137
Actively Recruiting
27
Universitatsklinikum Carl Gustav Carus
Dresden, Germany, D-01307
Actively Recruiting
28
Universitätsklinik
Düsseldorf, Germany
Actively Recruiting
29
Helios Klinikum Erfurt GmbH, Klinik für Kinderheilkunde
Erfurt, Germany, 99089
Actively Recruiting
30
Universitaets - Kinderklinik
Erlangen, Germany, 91054
Actively Recruiting
31
Universitaetsklinikum Essen
Essen, Germany, D-45147
Actively Recruiting
32
Klinikum der J.W. Goethe Universitaet
Frankfurt, Germany, D-60590
Actively Recruiting
33
Universitaetskinderklinik - Universitaetsklinikum Freiburg
Freiburg im Breisgau, Germany, D-79106
Actively Recruiting
34
Klinikum der Justus-Liebig-Universität, Zentrum für Kinderheilkunde, Abt. Hämatologie/Onkologie
Giessen, Germany, 35385
Actively Recruiting
35
Universitäts-Kinderklinik Päd. I, Hämatologie/Onkologie
Göttingen, Germany, 37099
Actively Recruiting
36
Klinik und Poliklinik für Kinder und Jugendmedizin, Allgemeine Pädiatrie mit Poliklinik/Pädiatrische Onkologie und Hämatologie
Greifswald, Germany, 17475
Actively Recruiting
37
Medizinische Hochschule Hannover, Zentrum Kinderheilkunde u. Jugendmedizin
Hanover, Germany, 30625
Actively Recruiting
38
Universitäts-Kinderklinik, Päd. Onkologie, Hämatologie, und Immunologie
Heidelberg, Germany, 69120
Actively Recruiting
39
Klinikum Heilbronn GmbH, Klinik für Kinderheilkunde und Jugendmedizin/Perinatalzentrum
Heilbronn, Germany, 74078
Actively Recruiting
40
Gemeinschaftskrankenhaus Herdecke, Kinderabteilung
Herdecke, Germany, 58313
Actively Recruiting
41
Universitaetsklinikum des Saarlandes
Homburg, Germany, 66421
Actively Recruiting
42
Klinikum, der Friedrich-Schiller-Universität, Klinik für Kinder- und Jugendmedizin
Jena, Germany, 7740
Actively Recruiting
43
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Germany, 76133
Actively Recruiting
44
Klinikum Kassel
Kassel, Germany, D-34125
Actively Recruiting
45
Klinik für Allgemeine Paediatrie, Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany, 24105
Actively Recruiting
46
Department für Frauen- und Kindermedizin, Abteilung für Pädiatrische Onkologie, Hämatologie und Hämostaseologie
Leipzig, Germany, 04103
Actively Recruiting
47
Universität zu Lübeck, Klinik für Kinder- u. Jugendmedizin, Abt. Hämatologie/ Onkologie/Immunologie
Lübeck, Germany, 23538
Actively Recruiting
48
Universitätsklinikum Magdeburg, Klinik für Päd. Hämatologie/Onkologie
Magdeburg, Germany, 39120
Actively Recruiting
49
Klinikum Mannheim gGmbH, Kinderklinik, Abt. Hämatologie/Onkologie
Mannheim, Germany, 68167
Actively Recruiting
50
Universitätsklinikum
Mannheim, Germany
Actively Recruiting
51
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Actively Recruiting
52
Städt. Krankenhaus München GmbH, Krankenhaus München-Schwabingen, Kinderklinik d. TU
München, Germany, 80804
Actively Recruiting
53
Ludwig-Maximilian-Universität, Dr. von Haunersches Kinderspital
München, Germany
Actively Recruiting
54
Universitäts-Kinderklinik, Päd. Hämatologie und Onkologie
Münster, Germany, 48149
Actively Recruiting
55
Cnopf'sche Kinderklinik, Onkologie
Nuremberg, Germany, 90419
Actively Recruiting
56
Klinikum Oldenburg gGmbH, Zentrum für Kinder- u. Jugendmedizin, (Elisabeth Kinderkrankenhaus)
Oldenburg, Germany, 26133
Actively Recruiting
57
Universitätsklinikum
Regensburg, Germany
Actively Recruiting
58
Universitäts-Kinderklinik
Rostock, Germany, 18055
Actively Recruiting
59
Asklepios-Klinik, Sankt Augustin GmbH
Sankt Augustin, Germany, 53757
Actively Recruiting
60
HELIOS Kliniken Schwerin, Klinik f. Kinder-u. Jugendmedizin
Schwerin, Germany, 19049
Actively Recruiting
61
Olga-Hospital, Kinderklinik, Pädiatrisches Zentrum, Abt. Hämatologie/Onkologie
Stuttgart, Germany, 70176
Actively Recruiting
62
Krankenanstalt Trier, Mutterhaus der Borromaeerinnen, Pädiatrische Abteilung
Trier, Germany, 54290
Actively Recruiting
63
Universitaetsklinikum Tuebingen
Tübingen, Germany, D-72076
Actively Recruiting
64
Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
Ulm, Germany, D-89075
Actively Recruiting
65
Stadtkrankenhaus, Kinderklinik
Wolfsburg, Germany, 38440
Actively Recruiting
66
Universitaets - Kinderklinik Wuerzburg
Würzburg, Germany, D-97080
Actively Recruiting
67
Soroka University Medical Center
Beersheba, Israel
Actively Recruiting
68
Rambam Health Care Campus
Haifa, Israel
Actively Recruiting
69
Hadassah Medical center
Jerusalem, Israel
Actively Recruiting
70
Schneider Children Medical Center of Israel
Petah Tikva, Israel
Actively Recruiting
71
Sheba Medical Center Tel-Hashomer
Ramat Gan, Israel
Actively Recruiting
72
Dana children hospital
Tel Aviv, Israel
Actively Recruiting
73
Azienda ospedali riuniti
Ancona, Italy
Actively Recruiting
74
AOUC Policlinico Bari
Bari, Italy
Actively Recruiting
75
A.O. Papa Giovanni XXIII
Bergamo, Italy
Actively Recruiting
76
Università di Bologna
Bologna, Italy
Actively Recruiting
77
ASST Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
78
Ospedale Businco
Cagliari, Italy
Actively Recruiting
79
Azienda ospedaliero universitaria
Catania, Italy
Actively Recruiting
80
AO Pugliese Ciaccio
Catanzaro, Italy
Actively Recruiting
81
S.O. Annunziata - A. O. Cosenza
Cosenza, Italy
Actively Recruiting
82
Ospedale Meyer
Florence, Italy
Actively Recruiting
83
Istituto Giannina Gaslini
Genova, Italy
Actively Recruiting
84
Policlinico di Modena Azienda Ospedaliero-Universitaria
Modena, Italy
Actively Recruiting
85
Clinica pediatrica Fondazione MBBM
Monza, Italy
Actively Recruiting
86
A.O.U. Vanvitelli
Naples, Italy
Actively Recruiting
87
AORN Santobono Pausilipon
Naples, Italy
Actively Recruiting
88
Azienda ospedaliera di Padova
Padova, Italy
Actively Recruiting
89
Ospedale Civico ARNAS Civico e Di Cristina
Palermo, Italy
Actively Recruiting
90
Azienda ospedaliero-universitaria di Parma
Parma, Italy
Actively Recruiting
91
Fondazione IRCCS Policlinico San Matteo
Pavia, Italy
Actively Recruiting
92
Ospedale S. Maria della misericordia
Perugia, Italy
Actively Recruiting
93
Ospedale Civile di Pescara
Pescara, Italy
Actively Recruiting
94
Ospedale Santa Chiara Pisa
Pisa, Italy
Actively Recruiting
95
Grande ospedale metropolitano B-M-M
Reggio Calabria, Italy
Actively Recruiting
96
Ospedale infermi
Rimini, Italy
Actively Recruiting
97
Fondazione Policlinico Gemelli
Roma, Italy
Actively Recruiting
98
Ospedale Bambino Gesù
Roma, Italy
Actively Recruiting
99
Policlinico Umberto I Università Sapienza di Roma
Roma, Italy
Actively Recruiting
100
Ospedale "Casa sollievo della sofferenza"
San Giovanni Rotondo, Italy
Actively Recruiting
101
A.O.U. Città della salute e della scienza di Torino
Torino, Italy
Actively Recruiting
102
IRCCS Burlo Garofolo
Trieste, Italy
Actively Recruiting
103
AOU Verona
Verona, Italy
Actively Recruiting
104
Klinika pediatrickej hematológie a onkológie SZU a DFNsP
Banská Bystrica, Slovakia
Actively Recruiting
105
Comenius University Children's Hospital
Bratislava, Slovakia
Actively Recruiting
106
Detská fakultná nemocnica Košice
Košice, Slovakia
Actively Recruiting
107
Kantonsspital Aarau
Aarau, Switzerland
Actively Recruiting
108
Universitäts-Kinderspital beider Basel
Basel, Switzerland
Actively Recruiting
109
Ospedale San Giovanni Bellinzona
Bellinzona, Switzerland
Actively Recruiting
110
Inselspital Bern
Bern, Switzerland
Actively Recruiting
111
HUG Hôpitaux Universitaires de Gèneve
Geneva, Switzerland
Actively Recruiting
112
CHUV Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
Actively Recruiting
113
Luzerner Kantonsspital-Kinderspital Luzern
Lucerne, Switzerland
Actively Recruiting
114
Ostschweizer Kinderspital
Sankt Gallen, Switzerland
Actively Recruiting
115
Universitäts-Kinderspital Zürich
Zurich, Switzerland
Actively Recruiting
Research Team
A
Anja Möricke, MD
CONTACT
L
Lile Bauer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
12
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