E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
leucémie aigue lymphoblastique |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10000845 |
E.1.2 | Term | Acute lymphoblastic leukemia |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. Pour les patients de risque standard ou intermédiaire, l'étude a deux objectifs principaux: 1) évaluer la supériorité en termes de PK (activité asparaginase) à J33 du régime fractionné 2) confirmer l'équivalence de toxicité des deux modalités d'administration (du J12 de l'induction au J49).
2. Dans le groupe haut risque/très haut risque, deux objectifs principaux ont été définis: 1) évaluer la PK (activité asparaginase) à J33 2) évaluer l'incidence de toxicités ciblées du J12 de l'induction au J49.
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
" Acute lymphoblastic leukemia (ALL) " B-or T-lineage NB: Children with Down syndrome are not eligible to randomization. See Section 5.3.2 " from >12 months to < 18 years old " Written informed consent obtained prior to any procedures for the protocol from the parents and the patient
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E.4 | Principal exclusion criteria |
Patients eligible for this study must not meet any of the following criteria: " L3 (Burkitt leukemia) as defined by the French-American-British (FAB) morphology classification " Secondary leukemia " Mixed Phenotype Acute Leukemia (MPAL according to WHO) " Patients previously treated with chemotherapy (steroid exposed pts 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
4.4 Exclusion criteria " Philadelphia positive/BCR-ABL acute lymphoblastic leukemia
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Activité asparaginase suffisante (> 100 UI/L) à J33 de l'induction 2. Toxicité : incidence des toxicités sévères (grade ? 3 du NCI) liées directement à l'asparaginase (thromboses veineuses du système nerveux central, pancréatite, anaphylaxie et hyperbilirubinémie) entre J12 (J1 pegaspargase) et J49 et dans tous les cas avant le J8 de la consolidation .
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 28 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |