Not yet taking people in GermanyPhase 3
Tests targeted treatments for children with acute lymphoblastic leukemia
Tests blinatumomab in children with standard-risk B-cell leukemia.
Key facts
- Who runs it
- Universitaetsklinikum Schleswig-Holstein AöR
- Where
- Aachen, Augsburg, Berlin, Brunswick, Chemnitz, Cologne, Cottbus, Dortmund, Dresden, Duesseldorf, Erfurt, Erlangen, Essen, Frankfurt Am Main, Freiburg im Breisgau, Giessen, Goettingen, Greifswald, Halle (Saale), Hanover, Heidelberg, Heilbronn, Herdecke, Homburg, Jena, Karlsruhe, Kassel, Kiel, Koblenz, Leipzig, Luebeck, Magdeburg, Mannheim, Minden, Muenster, Munich, Nuernberg, Oldenburg, Regensburg, Rostock, Sankt Augustin, Schwerin, Stuttgart, Tuebingen, Ulm, Witten, Wolfsburg, and Wuerzburg, GermanySee the 51 sites
- Trial code
- Registry title
- AIEOP-BFM ALL 2025 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 2,250 people, planned
- Started
- 1 Sept 2026
- Expected to end
- 31 Aug 2036
- Type of study
- Interventional
- Record updated
- 14 September 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teenagers under 18 with newly diagnosed acute lymphoblastic leukemia (ALL). A sub-protocol tests a shorter chemotherapy plus Blinatumomab in standard-risk B-cell ALL.
- Age
- Under 18 years (up to 17 years and 365 days) on the day of diagnosis.
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed ALL, or mixed phenotype acute leukemia (MPAL) treated like ALL. The B/SR sub-protocol needs standard-risk B-cell ALL.
- Earlier treatment
- No chemotherapy before the ALL diagnosis, except limited cytarabine (up to 100 mg/m² BSA for 2 days or less) or one dose of intrathecal triple therapy. No high-dose prednisolone-type steroids for more than two weeks in the last month. For the B/SR sub-protocol: standard induction and the first part of consolidation for low-risk B-ALL.
- Biomarker or test result
- Ph+ (BCR::ABL1 or t(9;22)-positive) ALL cannot join.
Main reasons for not taking part
- Ph+ (BCR::ABL1 or t(9;22)-positive) ALL
- Pregnancy or breastfeeding
- ALL that appeared as a second cancer after earlier chemotherapy or radiotherapy
- Another illness that does not allow standard ALL treatment
- Known HIV infection (B/SR sub-protocol)
The registry criteria, word for word
Show all 25 criteriaShow less
Who can take part
- Newly diagnosed acute lymphoblastic leukemia (ALL)
- Newly diagnosed mixed phenotype acute leukemia (MPAL) meeting one of the following criteria: (1) biphenotypic with a dominant lymphatic lineage assignment, (2) bilineal either with a dominant lymphoblastic population or if another reasonable rationale exists to treat the patient with an ALL-based therapy regimen
- Age < 18 years (up to 17 years and 365 days) at the day of diagnosis
- Written informed consent to the screening procedure in the Master protocol
- B/SR: Newly diagnosed ALL with B-cell immunology or newly diagnosed MPAL meeting the criteria of a biphenotypic acute leukemia with a dominant B lineage assignment
- B/SR: Meeting the criteria for the B-ALL standard-risk group
- B/SR: Prior treatment with a SOC induction and the first part of consolidation therapy for low-risk B-ALL according to the AIEOP-BFM ALL 2024 Treatment Recommendations including (1) prednisone pre-phase and (2) induction Protocol IA’ and (3) start of Consolidation A. Medically justified deviations from the protocol are permitted
- B/SR: Written informed consent to the trial participation and transfer and processing of data. The assent of the child must be obtained, as appropriate to the age of the patient and/or based on local regulations
Who cannot take part
- Pre-treatment with cytostatic drugs before ALL diagnosis. Exceptions include prior cytarabine treatment up to 100 mg/m² BSA for ≤ 2 days and/or a single dose of intrathecal triple therapy (Prednisolone, Cytarabine, and Methotrexate)
- Glucocorticoid pre-treatment with ≥ 1 mg/kg/d Prednisolone equivalent for more than two weeks during the last month before ALL diagnosis
- Sexually active adolescents not willing to use highly effective contraceptive method (pearl index <1) until 6 months (female) or 90 days (male) after end of anti-leukemic therapy
- B/SR: Live vaccine immunization within 2 weeks before start of Cons-Blina or Cons B-short
- ALL with other ABL class fusion if enrollment in a study specifically designed for these patients is possible or treatment with a tyrosine kinase inhibitor is planned
- Underlying disease that does not allow treatment according to a standard of care ALL protocol (e.g. Severe congenital heart disease, Charcot-Marie-Tooth Syndrome, Ataxia-teleangiectasia…)
- Other condition (either pre-existing or related to leukemia biology as present at diagnosis) or circumstances that significantly conflict with the treatment according to a standard of care ALL protoco
- ALL diagnosed as second malignancy and preceding chemotherapy and/or radiotherapy
- B/SR: Hypersensitivity to the active substance of Blinatumomab or to any of its ingredients
- B/SR: Clinically relevant CNS pathology requiring treatment (e.g., unstable epilepsy)
- B/SR: Known infection with human immunodeficiency virus (HIV)
- B/SR: History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or the national coordinator, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion
- Patients < 1 year of age with KMT2A-rearranged B-ALL if enrollment in a study specifically designed for these patients is possible
- Ph+ (BCR::ABL1 or t(9;22)-positive) ALL
- Evidence of pregnancy or lactation period
- Participation in another clinical trial except for add-on trials within the scope of supportive care approved by the sponsor
- B/SR: MPAL meeting the criteria of a bilineal acute leukemia with a lymphoblastic and a separate non-lymphoblastic blast subset
Where in Germany
- Universitaetsklinikum Aachen AöRAachen, GermanyNot yet recruiting
- Universitaetsklinikum AugsburgAugsburg, GermanyNot yet recruiting
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- HELIOS Klinikum Berlin Buch GmbHBerlin, GermanyNot yet recruiting
- Staedtisches Klinikum Braunschweig gGmbHBrunswick, GermanyNot yet recruiting
- Klinikum Chemnitz gGmbHChemnitz, GermanyNot yet recruiting
- Kliniken der Stadt Koeln gGmbHCologne, GermanyNot yet recruiting
- Universitaetsklinikum Koeln AöRCologne, GermanyNot yet recruiting
- Kommunale Traegergesellschaft Cottbus mbHCottbus, GermanyNot yet recruiting
- Klinikum Dortmund gGmbHDortmund, GermanyNot yet recruiting
- Technische Universitaet DresdenDresden, GermanyNot yet recruiting
- Universitaetsklinikum Duesseldorf AöRDuesseldorf, GermanyNot yet recruiting
- HELIOS Klinikum Erfurt GmbHErfurt, GermanyNot yet recruiting
- Universitaetsklinikum Erlangen AöRErlangen, GermanyNot yet recruiting
- Universitaetsklinikum Essen (AoR)Essen, GermanyNot yet recruiting
- Goethe University FrankfurtFrankfurt Am Main, GermanyNot yet recruiting
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyNot yet recruiting
- Justus-Liebig-Universitaet GiessenGiessen, GermanyNot yet recruiting
- Universitaetsmedizin GoettingenGoettingen, GermanyNot yet recruiting
- Universitaetsmedizin Greifswald KöRGreifswald, GermanyNot yet recruiting
- Martin-Luther-Universitaet Halle-WittenbergHalle (Saale), GermanyNot yet recruiting
- Medizinische Hochschule HannoverHanover, GermanyNot yet recruiting
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyNot yet recruiting
- SLK-Kliniken Heilbronn GmbHHeilbronn, GermanyNot yet recruiting
- Gemeinschaftskrankenhaus Herdecke gGmbHHerdecke, GermanyNot yet recruiting
- Universitaet Des SaarlandesHomburg, GermanyNot yet recruiting
- Universitaetsklinikum Jena KöRJena, GermanyNot yet recruiting
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, GermanyNot yet recruiting
- Klinikum Kassel GmbHKassel, GermanyNot yet recruiting
- Universitaetsklinikum Schleswig-Holstein AöRKiel, GermanyNot yet recruiting
- Gemeinschaftsklinikum Mittelrhein gGmbHKoblenz, GermanyNot yet recruiting
- Universitaet LeipzigLeipzig, GermanyNot yet recruiting
- Universitaetsklinikum Schleswig-Holstein AöRLuebeck, GermanyNot yet recruiting
- Otto Von Guericke Universitaet MagdeburgMagdeburg, GermanyNot yet recruiting
- Universitaetsklinikum Mannheim GmbHMannheim, GermanyNot yet recruiting
- Muehlenkreiskliniken AöRMinden, GermanyNot yet recruiting
- Universitaet MuensterMuenster, GermanyNot yet recruiting
- Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)Munich, GermanyNot yet recruiting
- LMU Klinikum Muenchen AöRMunich, GermanyNot yet recruiting
- Klinik Hallerwiese - Cnopfsche KinderklinikNuernberg, GermanyNot yet recruiting
- Klinikum Oldenburg AorOldenburg, GermanyNot yet recruiting
- Universitaetsklinikum Regensburg AöRRegensburg, GermanyNot yet recruiting
- Rostock University Medical CenterRostock, GermanyNot yet recruiting
- Asklepios-Klinik, Sankt Augustin GmbHSankt Augustin, GermanyNot yet recruiting
- HELIOS Kliniken Schwerin GmbHSchwerin, GermanyNot yet recruiting
- Klinikum Der Landeshauptstadt Stuttgart gKAöRStuttgart, GermanyNot yet recruiting
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyNot yet recruiting
- Universitaetsklinikum Ulm AoRUlm, GermanyNot yet recruiting
- Private Universitaet Witten/Herdecke gGmbHWitten, GermanyNot yet recruiting
- Klinikum WolfsburgWolfsburg, GermanyNot yet recruiting
- Universitaetsklinikum Wuerzburg AöRWuerzburg, GermanyNot yet recruiting
About the trial
What the trial wants to find out
Master protocol: To improve the outcome of children and adolescents with ALL by implementing targeted therapies (either immunotherapy or small molecules targeting leukaemia-related signalling pathways) as randomised or non-randomised modular interventions (sub-protocols) applying an improved risk-adapted treatment stratification system based on clinical parameters, genetics and in-vivo response. Sub-protocol B/SR: To provide therapy that reduces the treatment burden without affecting leukemia outcome to Standard Risk B-ALL patients by the treatment with a reduced-intensity post-induction chemotherapy combined with one cycle of Blinatumomab (28 days) replacing the standard-of-care post-induction chemotherapy (R-SR).
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- AIEOP-BFM ALL 2025 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
- Plain-language title
- Tests targeted treatments for children with acute lymphoblastic leukemiaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 14 September 2026