Clinical trial • Oncology|Immunology|Haematology
PEGASPARGASE for Acute lymphoblastic leukaemia (ALL)
Clinical trial of PEGASPARGASE for Acute lymphoblastic leukaemia (ALL). open-label. 1636 participants.
Overview
- Trial Therapeutic Area
- Oncology|Immunology|Haematology
- Trial Disease
- Acute lymphoblastic leukaemia (ALL)
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 19-09-2024
- First CTIS Authorization Date
- 10-10-2024
Trial design
open-label trial in France.
- Open Label
- Yes
- Biomarker Stratified
- True, Immunophenotypic characterization: B-lineage vs T-lineage
- Target Sample Size
- 1636
Stratification factors
- Immunophenotypic characterization (B- or T- lineage)
- Patient risk group
Eligibility
Recruits 1636 paediatric patients.
- Vulnerable Population
- Selected vulnerable population: children and adolescents (age > 12 months to < 18 years). Written informed consent obtained before day 8 of treatment.
Inclusion criteria
- {"criterion_text":"- · Children and adolescents Age > 12 months but < 18 yearsB-lineage or T- lineage ALL"}
- {"criterion_text":"- · Written informed consent obtained before day 8 of treatment"}
Exclusion criteria
- {"criterion_text":"- · Ph+/BCR-ABL ALL (ESPhALL protocol)"}
- {"criterion_text":"- · CNS thrombosis before D12"}
Endpoints
Primary endpoints
- {"endpoint_text":"- o Adequate asparaginase activity (>100 IU/L) at D33 of induction","definition_or_measurement_approach":"Asparaginase enzymatic activity measured at day 33 of induction; target threshold >100 IU/L."}
- {"endpoint_text":"- o Toxicity: Incidence of severe toxicities (Grade ≥ 3) directly asparaginaserelated (CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia) between D12 and D49 of treatment and anyway before D8 of consolidation","definition_or_measurement_approach":"Incidence of Grade ≥ 3 adverse events judged directly asparaginase-related occurring between day 12 and day 49 of treatment (and before day 8 of consolidation); events include CNS thrombosis, pancreatitis, anaphylaxia, and hyperbilirubinemia."}
Secondary endpoints
- {"endpoint_text":"- - to evaluate the incidence of rare subgroups of ALL and their prognostic value e.g. so-called “B-other” subgroup: BCR-ABL like (including EBF1-PDGFRB), MEF2D-X, ZNF384-X, TCF3-HLF…","definition_or_measurement_approach":"Assessment of incidence of molecular/cytogenetic rare ALL subgroups and analysis of their prognostic value."}
- {"endpoint_text":"- - 5 year EFS, DFS and OS of the rare patients with suboptimal response to therapy (induction failure or MRDTP1 ≥ 10-3) and ABL-class fusions ALLs treated with imatinib","definition_or_measurement_approach":"Five-year event-free survival (EFS), disease-free survival (DFS) and overall survival (OS) for specified patient subgroups; measured at 5 years."}
- {"endpoint_text":"- - Imatinib related adverse events (immediate and long term, cf appendix 9) in the rare patients with suboptimal response to therapy (induction failure or MRDTP1 ≥ 10-3) and ABL-class fusions ALLs treated with imatinib","definition_or_measurement_approach":"Collection and analysis of immediate and long-term adverse events related to imatinib in the specified patient subgroup."}
Recruitment
- Planned Sample Size
- 1636
- Recruitment Window Months
- 105
- Consent Approach
- Written informed consent obtained before day 8 of treatment.
Geography
- Total Number Of Sites
- 28
- Total Number Of Participants
- 1636
France
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 554
- Number Of Sites
- 28
- Number Of Participants
- 1636
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Service d’Hémato-Immunologie
- Principal Investigator Name
- André BARUCHEL
- Principal Investigator Email
- andre.baruchel@aphp.fr
- Contact Person Name
- André BARUCHEL
- Contact Person Email
- andre.baruchel@aphp.fr
- Site Name
- CHU Limoges / Hôpital de la Mère et de l’Enfant
- Department Name
- Service d'Hématologie - Oncologie pédiatrique
- Principal Investigator Name
- PIGUET Christophe
- Principal Investigator Email
- christophe.piguet@chu-limoges.fr
- Contact Person Name
- PIGUET Christophe
- Contact Person Email
- christophe.piguet@chu-limoges.fr
- Site Name
- CHU Brest / Hôpital Morvan
- Department Name
- Département de Pédiatrie et Génétique Médicale CHRU Morvan
- Principal Investigator Name
- CARAUSU Liana
- Principal Investigator Email
- liana.carausu@chu-brest.fr
- Contact Person Name
- CARAUSU Liana
- Contact Person Email
- liana.carausu@chu-brest.fr
- Site Name
- CHU Besancon
- Department Name
- Hématologie Oncologie pédiatrique
- Principal Investigator Name
- SIMON Pauline
- Principal Investigator Email
- p1simon@chu-besancon.fr
- Contact Person Name
- SIMON Pauline
- Contact Person Email
- p1simon@chu-besancon.fr
- Site Name
- CHU Dijon Bourgogne Hôpital François Mitterand
- Department Name
- Service Immuno-Hématologie Oncologie Pédiatrique
- Principal Investigator Name
- DESPLNATES Claire
- Principal Investigator Email
- claire.desplantes@chu-dijon.fr
- Contact Person Name
- DESPLNATES Claire
- Contact Person Email
- claire.desplantes@chu-dijon.fr
- Site Name
- CHU CLERMONT FERRAND - Hôpital Estaing,
- Department Name
- Unité Onco- Hématologie Pédiatrique
- Principal Investigator Name
- KANOLD Justyne
- Principal Investigator Email
- jkanold@chu-clermontferrand.fr
- Contact Person Name
- KANOLD Justyne
- Contact Person Email
- jkanold@chu-clermontferrand.fr
- Site Name
- CHU Angers
- Department Name
- Pôle Femme Mère Enfant ; Unité d’Hématologie/Oncologie pédiatrique
- Principal Investigator Name
- PELLIER Isabelle
- Principal Investigator Email
- ispellier@chu-angers.fr
- Contact Person Name
- PELLIER Isabelle
- Contact Person Email
- ispellier@chu-angers.fr
- Site Name
- CHU Bordeaux Haut-Leveque
- Department Name
- Hôpital de Enfants, Unité Onco-Hématologie Pédiatrique
- Principal Investigator Name
- DUCASSOU Stéphane
- Principal Investigator Email
- stephane.ducassou@chu-bordeaux.fr
- Contact Person Name
- DUCASSOU Stéphane
- Contact Person Email
- stephane.ducassou@chu-bordeaux.fr
- Site Name
- CHU Amiens-Picardie - Site Sud
- Department Name
- Service d’oncolologie, Hématologie pédiatrique
- Principal Investigator Name
- LEGLISE Camille
- Principal Investigator Email
- leglise.camille@chu-amiens.fr
- Contact Person Name
- LEGLISE Camille
- Contact Person Email
- leglise.camille@chu-amiens.fr
- Site Name
- CHU Caen
- Department Name
- Unité d'hémato-immuno-oncologie pédiatrique
- Principal Investigator Name
- BODET Damien
- Principal Investigator Email
- bodet-d@chu-caen.fr
- Contact Person Name
- BODET Damien
- Contact Person Email
- bodet-d@chu-caen.fr
- Site Name
- CHU Lille Hopital Jeanne de Flandre
- Department Name
- Unité d'hématologie pédiatrique
- Principal Investigator Name
- Abou Chahla Wadih
- Principal Investigator Email
- wadih.abouchahla@chru-lille.fr
- Contact Person Name
- Abou Chahla Wadih
- Contact Person Email
- wadih.abouchahla@chru-lille.fr
- Site Name
- CHU Grenoble Alpes
- Department Name
- Service onco hématologie pédiatrique
- Principal Investigator Name
- ARMARI ALLA Corinne
- Principal Investigator Email
- CArmariAlla@chu-grenoble.fr
- Contact Person Name
- ARMARI ALLA Corinne
- Contact Person Email
- CArmariAlla@chu-grenoble.fr
- Site Name
- CHU Croix Rousse-Lyon
- Department Name
- Service d'immuno-hématologie pédiatrique et de transplantation de moelle osseuse
- Principal Investigator Name
- HALFON-DOMENECH Carine
- Principal Investigator Email
- carine.halfondomenech@ihope.fr
- Contact Person Name
- HALFON-DOMENECH Carine
- Contact Person Email
- carine.halfondomenech@ihope.fr
- Site Name
- CHU de Montpellier
- Department Name
- UAM Hématologie et Oncologie Pédiatrique
- Principal Investigator Name
- HAOUY Stéphanie
- Principal Investigator Email
- s-haouy@chu-montpellier.fr
- Contact Person Name
- HAOUY Stéphanie
- Contact Person Email
- s-haouy@chu-montpellier.fr
- Site Name
- CHU Nantes - HME-Department onco-hematology pédiatric
- Department Name
- Service d'hématologie et oncologie pédiatriques
- Principal Investigator Name
- THOMAS Caroline
- Principal Investigator Email
- caroline.thomas@chu-nantes.fr
- Contact Person Name
- THOMAS Caroline
- Contact Person Email
- caroline.thomas@chu-nantes.fr
- Site Name
- CHU de Nancy – Hôpitaux de Brabois
- Department Name
- Service d'hémato-oncologie pédiatrique
- Principal Investigator Name
- LUBNAU Marion
- Principal Investigator Email
- m.lubnau@chru-nancy.fr
- Contact Person Name
- LUBNAU Marion
- Contact Person Email
- m.lubnau@chru-nancy.fr
- Site Name
- CHU Marseille - Hôpital Nord
- Department Name
- Service de Pédiatrie et hématologie pédiatrique
- Principal Investigator Name
- MICHEL Gerard
- Principal Investigator Email
- gmichel@ap-hm.fr
- Contact Person Name
- MICHEL Gerard
- Contact Person Email
- gmichel@ap-hm.fr
- Site Name
- CHU Saint Etienne Hôpital Nord
- Department Name
- Pôle mère enfant-Unité Hématologie - Oncologie pédiatrique
- Principal Investigator Name
- THOUVENIN-DOULET Sandrine
- Principal Investigator Email
- sandrine.thouvenin@chu-st-etienne.fr
- Contact Person Name
- THOUVENIN-DOULET Sandrine
- Contact Person Email
- sandrine.thouvenin@chu-st-etienne.fr
- Site Name
- CHU de Tours - Hôpital Clocheville
- Department Name
- Service d'Onco-Hématologie Pediatrique
- Principal Investigator Name
- LEJEUNE Julien
- Principal Investigator Email
- j.lejeune@chu-tours.fr
- Contact Person Name
- LEJEUNE Julien
- Contact Person Email
- j.lejeune@chu-tours.fr
- Site Name
- Trousseau Hospital
- Department Name
- Service Hémato-immuno- oncologie
- Principal Investigator Name
- PETIT Arnaud
- Principal Investigator Email
- arnaud.petit@trs.aphp.fr
- Contact Person Name
- PETIT Arnaud
- Contact Person Email
- arnaud.petit@trs.aphp.fr
- Site Name
- CHU de Poitiers
- Department Name
- Service Oncologie-Hématologie pédiatrique
- Principal Investigator Name
- DUPRAZ Chrystelle
- Principal Investigator Email
- Chrystelle.dupraz@chu-poitiers.fr
- Contact Person Name
- DUPRAZ Chrystelle
- Contact Person Email
- Chrystelle.dupraz@chu-poitiers.fr
- Site Name
- CHU de Nice Archet
- Department Name
- Service d'hémato-oncologie pédiatrique
- Principal Investigator Name
- ROHRLICH Pierre Simon
- Principal Investigator Email
- rohrlich.ps@chu-nice.fr
- Contact Person Name
- ROHRLICH Pierre Simon
- Contact Person Email
- rohrlich.ps@chu-nice.fr
- Site Name
- CHU de Rouen - Hôpital Charles Nicolle
- Department Name
- Hémato-cancérologie pédiatrique
- Principal Investigator Name
- SCHNEIDER Pascale
- Principal Investigator Email
- pascale.schneider@chu-rouen.fr
- Contact Person Name
- SCHNEIDER Pascale
- Contact Person Email
- pascale.schneider@chu-rouen.fr
- Site Name
- Hôpital Saint-Louis
- Department Name
- Unité Hématologie Adolescents et Jeunes Adultes
- Principal Investigator Name
- BOISSEL Nicolas
- Principal Investigator Email
- nicolas.boissel@sls.aphp.fr
- Contact Person Name
- BOISSEL Nicolas
- Contact Person Email
- nicolas.boissel@sls.aphp.fr
- Site Name
- CHU de Rennes
- Department Name
- Pôle pédiatrieHémato-cancérologie pédiatrique
- Principal Investigator Name
- GANDEMER Virginie
- Principal Investigator Email
- virginie.gandemer@chu-rennes.fr
- Contact Person Name
- GANDEMER Virginie
- Contact Person Email
- virginie.gandemer@chu-rennes.fr
- Site Name
- CHU Strasbourg - Hôpital de Hautepierre
- Department Name
- Service d'Onco-Hématologie Pédiatrique
- Principal Investigator Name
- PAILLARD Catherine
- Principal Investigator Email
- catherine.paillard@chru-strasbourg.fr
- Contact Person Name
- PAILLARD Catherine
- Contact Person Email
- catherine.paillard@chru-strasbourg.fr
- Site Name
- CHU Toulouse
- Department Name
- Service Pédiatrie - Hématologie Immunologie Oncologie
- Principal Investigator Name
- PASQUET Marlène
- Principal Investigator Email
- pasquet.m@chu-toulouse.fr
- Contact Person Name
- PASQUET Marlène
- Contact Person Email
- pasquet.m@chu-toulouse.fr
- Site Name
- CHU Reims – Hôpital Maison Blanche
- Department Name
- Service d'Hémato-Oncologie Pédiatrique-
- Principal Investigator Name
- PLUCHART Claire
- Principal Investigator Email
- cpluchart@chu-reims.fr
- Contact Person Name
- PLUCHART Claire
- Contact Person Email
- cpluchart@chu-reims.fr
Sponsor
Primary sponsor
- Full Name
- Assistance Publique Hopitaux De Paris
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- PEGASPARGASE
- Active Substance
- PEGASPARGASE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INJECTION
- Route
- INJECTION
- Authorisation Status
- Authorised
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