Tests a treatment plan for children with non-mature-B acute lymphoblastic leukemia
Compares treatment strategies in children with childhood non-mature-B acute lymphoblastic leukemia.
Key facts
- Who runs it
- Semmelweis University
- Where
- Athens, Heraklion, Marousi, and Thessaloniki, GreeceSee the 6 sitesAlso in 3 other countries, 9 sites
- Trial code
- Registry title
- ALLIC 2022 international clinical investigation for advanced management of childhood acute lymphoblastic leukemia
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 775 people, planned
- Started
- 9 Dec 2024
- Expected to end
- 31 Dec 2035
- Type of study
- Interventional
- Record updated
- 1 June 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 newly diagnosed with acute lymphoblastic leukemia (ALL) who have not yet started induction treatment within the trial's enrollment period.
- Age
- From 1 year up to under 18 years at diagnosis.
- Sex
- Boys and girls can both join.
- Disease stage
- Newly diagnosed acute lymphoblastic leukemia (ALL), confirmed by all the diagnostic criteria in the protocol. The title names non-mature-B ALL.
- Earlier treatment
- Induction therapy must start between December 1st, 2022 and December 31, 2028.
- Biomarker or test result
- Girls who could become pregnant must have a negative urine βHCG test.
Main reasons for not taking part
- Positive hepatitis B (HBV) blood test results, and tuberculosis (TBC) documentation
- Pregnant or breastfeeding patients
- Known allergy or contraindication to both study drugs (IMPs)
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- Age at diagnosis 1- <18 years
- Start of induction therapy within the enrollment period of the trial: from December 1st, 2022 through December 31, 2028; 3- Diagnosis of ALL ensured by all the diagnostic criteria defined in the protocol; 4.Informed consent to participate in ALL IC-BFM 2022 trial available
- Admission, diagnosis, and therapy performed by a center participating in the study
- Urine βHCG is negative in female patient with childbearing potential
Who cannot take part
- Positive HBV serology (hepatitis B surface (HBs) antigen positive and HBc antibody positive/HBs antibody negative) and TBC documentation
- Known allergy or contraindication (based on SmPC) to both IMPs
- Pregnant or breastfeeding patient
Where in Greece
Also in 3 other countries, 9 sites
- Athens General Children's Hospital Panagioti And Aglaia KyriakouAthens, GreeceTaking people
- Nosokomeio Paidon I Agia SofiaAthens, GreeceTaking people
- University General Hospital of HeraklionHeraklion, GreeceTaking people
- Mitera S.A.Marousi, GreeceTaking people
- Ippokratio General Hospital of ThessalonikiThessaloniki, GreeceTaking people
- University General Hospital of Thessaloniki - AHEPAThessaloniki, GreeceTaking people
About the trial
What the trial wants to find out
The objectives for the ALLIC-BFM 2022 Protocol are directed to improve survival rates, to reduce morbidity and mortality and to answer randomized questions, in order to find new strategies for achieving a more accurate treatment for children with ALL. The aims will be the following: 1. To improve the EFS probability of children with ALL. 2. To achieve a better risk group definition: 2.1. Improving genetic studies at diagnosis. 2.2. Adding MRD determinations on day 33 and day 78 by Flow-Cytometry (FC). 3. To decrease deaths during induction phase rate and deaths in Complete Remission rate. 4. To evaluate the role of intensified treatment element with PEG-asparaginase (Peg-Asp). 5. To evaluate the impact of immunotherapy (anti CD20) for Bcp-ALL patients.
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
- A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia
- Plain-language title
- Tests a treatment plan for children with non-mature-B 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
- 1 June 2026