Authorised Therapeutic use (Phase IV) Childhood non-mature-B Acute Lymphoblastic Leukemia

ALLIC 2022 international clinical investigation for advanced management of childhood acute lymphoblastic leukemia

EU CTIS ID: 2024-513824-41-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

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

  • Age at diagnosis 1- <18 years.
  • 2. 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.
  • 5. Admission, diagnosis, and therapy performed by a center participating in the study.
  • 6. Urine βHCG is negative in female patient with childbearing potential.

You likely can't join if

  • Positive HBV serology (hepatitis B surface (HBs) antigen positive and HBc antibody positive/HBs antibody negative) and TBC documentation.
  • Pregnant or breastfeeding patient
  • Known allergy or contraindication (based on SmPC) to both IMPs

The study team makes the final eligibility decision.

Where it's taking place

  • Chile
  • Argentina
  • Serbia
  • Uruguay

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 Chile; Argentina; Serbia; Uruguay. 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.