Immunotherapy in B-Cell Acute Lymphoblastic Leukemia.
Kara L Davis, Catherine C Yao, Jessica A O Zimmerman...
https://pubmed.ncbi.nlm.nih.gov/41671463Actively Recruiting
Phase 3
Age: 0 - 17Years
All Genders
ID03643276
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia Using Immunotherapy and Chemotherapy - AIEOP-BFM ALL 2017
Led by Martin Schrappe · Updated on 2025-04-06
5000
Participants Needed
115
Research Sites
N/A
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
Researchers are studying acute lymphoblastic leukemia (ALL) in children and adolescents, recognizing it as a diverse disease with complex genetic features. The study aims to improve treatment by using more precise risk assessments and testing immunotherapy as an alternative to intensive chemotherapy, especially for patients at high risk of relapse. It also explores targeted therapy to overcome chemotherapy resistance and evaluates extended chemotherapy for T-cell ALL patients with slower treatment responses. The study divides patients into risk groups based on leukemia type, genetics, and treatment response, then tests different experimental treatments alongside standard chemotherapy. These include the proteasome inhibitor bortezomib during consolidation for high-risk B-cell ALL, immunotherapy with blinatumomab replacing intensive chemotherapy in high-risk patients, and blinatumomab for intermediate-risk patients. T-cell ALL patients receive extended consolidation chemotherapy to reduce relapse risk. Participants undergo a series of treatment phases including induction, consolidation, extra-compartment, reinduction, and maintenance therapy lasting up to two years after diagnosis. Treatments include various chemotherapy drugs and immunotherapy cycles depending on the assigned group. Researchers monitor outcomes such as event-free and disease-free survival over up to ten years, along with treatment toxicity and minimal residual disease response. Some high-risk patients may receive stem cell transplants or cranial irradiation as part of their treatment plan.
CONDITIONS
Brief Title
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017
Who Can Participate
Age: 0 - 17Years
All Genders
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute lymphoblastic leukemia or related mixed phenotype acute leukemia with dominant T or B lineage
- Newly diagnosed acute undifferentiated leukemia
- Age under 18 years at diagnosis (up to 17 years and 365 days)
- Enrollment at a participating center
- Written informed consent for trial participation and data processing
You will not qualify if you...
- Philadelphia chromosome-positive (Ph+) ALL
- Bilineal leukemia with significant non-lymphoblastic blasts
- Prior treatment with cytostatic drugs
- Glucocorticoid pre-treatment of 1 mg/kg/day or more for over two weeks in the last month before diagnosis
- Treatment started under a different protocol
- Underlying diseases preventing protocol treatment (e.g., severe heart disease, Charcot-Marie Syndrome, Ataxia-Telangiectasia)
- ALL as a second malignancy following chemotherapy or radiotherapy
- Pregnancy or lactation
- Sexually active adolescents unwilling to use highly effective contraception until 12 months post-therapy
- Participation in another clinical trial except approved supportive care add-ons
- Live vaccine immunization within 2 weeks prior to protocol treatment start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Induction Treatment
Duration - 5 weeks
Participants receive initial chemotherapy including prednisolone, vincristine, daunorubicin, pegaspargase, and intrathecal methotrexate as part of the induction phase.
Weekly visits during induction
Consolidation Treatment
Duration - 4 to 6 weeks
Participants undergo risk-stratified consolidation therapy which may include chemotherapy drugs like cyclophosphamide, cytarabine, 6-mercaptopurine, dexamethasone, vincristine, and pegaspargase. Experimental treatments such as bortezomib or extension of consolidation phase may be added depending on the participant's risk group and randomization.
Weekly visits during consolidation
Extra-Compartment Phase
Duration - 8 weeks
Participants receive additional chemotherapy with drugs including 6-mercaptopurine, high-dose methotrexate, and intrathecal methotrexate to target leukemic cells outside the bone marrow.
Regular visits during extra-compartment phase
Reinduction Treatment
Duration - 6 weeks
Participants receive reinduction chemotherapy with dexamethasone, vincristine, doxorubicin, pegaspargase, intrathecal methotrexate, cyclophosphamide, tioguanine, and cytarabine to further reduce leukemia burden.
Weekly visits during reinduction
Post-Consolidation Immunotherapy
Duration - 28 days per cycle, up to 2 cycles
Selected participants receive immunotherapy with blinatumomab as part of experimental treatment to improve disease-free survival, replacing some chemotherapy cycles depending on risk group and randomization.
1 to 2 visits per cycle (in-person)
Maintenance Treatment
Duration - Up to 2 years
Participants receive maintenance chemotherapy with 6-mercaptopurine and methotrexate for up to 2 years after initial diagnosis to maintain remission.
Monthly visits during maintenance
Intensified Consolidation and Additional Treatments
Duration - Variable, generally several weeks
Participants at high relapse risk may receive intensified chemotherapy blocks and additional treatments such as Myocet-FLA or allogeneic stem cell transplantation after consolidation, depending on response and risk stratification.
Multiple visits depending on treatment cycles
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
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Research Team
A
Anja Möricke, MD
L
Lile Bauer
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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