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AIEOP-BFM ALL 2025 - International collaborative treatment protocol for children and adolescents with acute lymphoblastic leukemia
EU CTIS ID: 2025-522190-11-01
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Ph+ (BCR::ABL1 or t(9;22)-positive) ALL
- Patients < 1 year of age with KMT2A-rearranged B-ALL if enrollment in a study specifically designed for these patients is possible
- 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
- 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
See the full eligibility criteria
- 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
- Ph+ (BCR::ABL1 or t(9;22)-positive) ALL
- Patients < 1 year of age with KMT2A-rearranged B-ALL if enrollment in a study specifically designed for these patients is possible
- 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
- 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
- Evidence of pregnancy or lactation period
- B/SR: Hypersensitivity to the active substance of Blinatumomab or to any of its ingredients
- 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
- 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
- B/SR: Clinically relevant CNS pathology requiring treatment (e.g., unstable epilepsy)
- B/SR: Known infection with human immunodeficiency virus (HIV)
- B/SR: Live vaccine immunization within 2 weeks before start of Cons-Blina or Cons B-short
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Australia
- Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Australia; Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.