ALLIC 2022 international clinical investigation for advanced management of childhood acute lymphoblastic leukemia
Key facts
- Where
- Budapest, Budapest VIII, Debrecen, Miskolc, Pécs és Szeged, MagyarországSee the 6 sites
- Phase
- 4. fázis
Where in Magyarország
- Semmelweis UniversityBudapest, MagyarországTaking people
- Heim Pal Orszagos Gyermekgyogyaszati IntezetBudapest VIII, MagyarországTaking people
- University of DebrecenDebrecen, MagyarországTaking people
- Borsod-Abauj-Zemplen Varmegyei Koezponti Korhaz Es Egyetemi OktatokorhazMiskolc, MagyarországTaking people
- University of PecsPécs, MagyarországTaking people
- University of SzegedSzeged, MagyarországTaking people
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?
Trial details
- Who runs it
- Semmelweis University
- Trial code
- EU 2024-513824-41-00
- Record updated
- 2026. június 1.
- Original description
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.Read full original descriptionShow less
A Randomized Trial of the I-BFM-SG for the Management of Childhood non-mature-B Acute Lymphoblastic Leukemia
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.
Inclusion: 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.
Exclusion: 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.