2024-513824-41-00RecruitingPhase 4
ALLIC 2022 international clinical investigation for advanced management of childhood acute lymphoblastic leukemia
A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia
Source: EU CTIS (euclinicaltrials.eu) · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 775 (estimated)
- First submitted
- 7 Jun 2024
- Start date
- 9 Dec 2024
- Lead sponsor
- Semmelweis University
- Diseases
- Acute lymphoblastic leukaemia
- EU CT number
- 2024-513824-41-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 775
- 15 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnant or breastfeeding patient
Who the study is looking for
- 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.
Age in the registry: - to 17 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Athens General Children's Hospital Panagioti And Aglaia Kyriakou | Athens | Greece | Recruiting |
| Nosokomeio Paidon I Agia Sofia | Athens | Greece | Recruiting |
| University General Hospital of Heraklion | Heraklion | Greece | Recruiting |
| Mitera S.A. | Marousi | Greece | Recruiting |
| Ippokratio General Hospital of Thessaloniki | Thessaloniki | Greece | Recruiting |
| University General Hospital of Thessaloniki - AHEPA | Thessaloniki | Greece | Recruiting |
| University Hospital Centre Zagreb | Zagreb | Croatia | Recruiting |
| Children's Hospital Zagreb | Zagreb | Croatia | Recruiting |
| Semmelweis University | Budapest | Hungary | Recruiting |
| Heim Pal Orszagos Gyermekgyogyaszati Intezet | Budapest VIII | Hungary | Recruiting |
| University of Debrecen | Debrecen | Hungary | Recruiting |
| Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi Oktatokorhaz | Miskolc | Hungary | Recruiting |
| University of Pecs | Pécs | Hungary | Recruiting |
| University of Szeged | Szeged | Hungary | Recruiting |
| University Medical Center Ljubljana | Ljubljana | Slovenia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.