Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT02716233
Eligibility Criteria:
Inclusion Criteria:
* Children and adolescents Age \> 12 months but \< 18 yearsB-lineage or T- lineage ALL
* Written informed consent obtained before day 8 of treatment
Non inclusion criteria:
* L3 (Burkitt's leukemia) (LMB type protocols)
* Mixed Phenotype Acute Leukemia (WHO criteria).
* Infant ALL (age ≤ 365 days (Interfant 06 protocol)
* Secondary leukemia
* Patients previously treated with chemotherapy (steroid exposed patients can be included and stratified according to Section 3.5) Known allergy to pegylated products
* Pregnancy. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant must have a negative serum pregnancy before inclusion and a reliable contraception except oral contraceptives. The contraception should be maintained throughout the study and for 3 months after treatment discontinuation.
* Known HIV positivity
* CNS thrombosis during Prophase
Exclusion Criteria:
* Ph+/BCR-ABL ALL (ESPhALL protocol)
* CNS thrombosis before D12
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
18 Years
Study:
NCT02716233
Study Brief:
Protocol Section:
NCT02716233