Authorised Therapeutic confirmatory (Phase III) This is a prospective, French, multicenter, open-label, design, stratified on the immunophenotypic characterization (B- or T- lineage) and the patient risk group, that aims at evaluating the efficacy and the tolerance of different schedules of pegaspargase in patients from 12 months to less than 18 years newly diagnosed with standard/medium-risk ALL

CAALL-F01: a French protocol for the treatment of acute lymphoblastic leukemia (ALL) in children and adolescents

EU CTIS ID: 2024-514243-29-01

What this study is testing

1. For children and adolescents with standard or medium risk ALL, the study has two primary objectives: 1) to assess the superiority in terms of PK at D33 of the fractionated scheme; 2) to assess the equivalence in the tolerance of the 2 schemes (from D12 of induction to D49) 2. In the High/Very High Risk group two primary objectives have been defined: 1) to assess the PK at D33; 2) to assess the toxicity of the intensified scheme from D12 of induction to D49

  • 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

  • · Children and adolescents Age > 12 months but < 18 yearsB-lineage or T- lineage ALL · Written informed consent obtained before day 8 of treatment

You likely can't join if

  • · Ph+/BCR-ABL ALL (ESPhALL protocol) · CNS thrombosis before D12

The study team makes the final eligibility decision.

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.

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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.