27:"/_next/static/immutable/chunks/1caiys5hgvzzo.js" 28:"/_next/static/immutable/chunks/1qmpoydqg-n72.js" 29:I[3292,["$4","$5","$6","$9","$a","$13","$27","$28"],"default"] 2a:Tc0a,This is a Phase 1/2, open-label, single arm, multicohort study incorporating Simon's Optimal two-stage design to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL. In the Phase 1, up to 5 dose levels will be of JCAR017 will be evaluated. Enrollment will commence in pediatric subjects with r/r B-ALL at Dose Level 1 (DL1) of 0.05x10\^6 CAR+ T cells/kg (maximum DL1 of 5x10\^6 JCAR017 CAR+ T cells \[non-weight adjusted\]). If this dose is confirmed to be safe and tolerable, additional subjects will be enrolled at higher dose(s) up to 0.75 x10\^6 CAR+ T cells/kg (maximum of 75x10\^6 JCAR017 CAR+ T cells \[non-weight adjusted\]) with the aim to identify the RP2D. Dose escalation/de-escalation will follow a modified toxicity probability interval (mTPI-2) algorithm. A Safety Review Committee (SRC) will recommend the Phase 2 dose (defined as RP2D) based on an integrated assessment of the safety, PK and preliminary efficacy information from at least 10 pediatric subjects treated at the RP2D. In Phase 2, a minimum of 71 additional subjects (\< 18 years of age) will be enrolled into one of the 3 cohorts listed below. The sample size for Cohorts 1 and 2 is calculated according to Simon's Optimal two-stage design. The 10 or more pediatric subjects treated at the RP2D in Phase 1 will form part of the sample size (ie, Cohort 1 and Cohort 2). Therefore, the protocol intends to treat 81 primary endpoint evaluable pediatric subjects in Phase 2, if warranted by the evaluation of results at the completion of the first stage of the study in each cohort. * Cohort 1 (r/r B-ALL): 48 evaluable pediatric subjects (13 subjects in Stage 1 and 35 in Stage 2) * Cohort 2 (MRD+ B-ALL): 23 evaluable pediatric subjects (9 subjects in Stage 1 and 14 subjects in Stage 2) * Cohort 3 (r/r B-NHL \[DLBCL, BL, or PMBCL\]): 10 evaluable pediatric subjects. Due to the very low incidence rate and therefore expected low subject accrual, there is no formal sample size for this arm. Up to 20 additional B-ALL subjects between 18 and 25 years of age may be enrolled in Phase 2. Following treatment with JCAR017 subjects will then enter the post-treatment period for disease progression/relapse, safety, CAR T cell persistence, and survival up to 24 months after administration of JCAR017. Efficacy will be assessed both locally and by an Independent Review Committee. Response assessments will be based on bone marrow and blood morphologic criteria, physical examination findings, along with laboratory assessments of cerebral spinal fluid (CSF) and bone marrow MRD (B-ALL only) assessments. B-NHL subjects will also have radiographic disease assessment by CT/MRI scans and tumor biopsies, if accessible. Post-study follow-up for survival, relapse, long-term toxicity, and lentiviral vector safety will continue under a separate long-term follow-up protocol for up to 15 years after the JCAR017 infusion as per health authority regulatory guidelines. An Independent Data Monitoring Committee will monitor the study conduct.2b:T22fe,Inclusion Criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Phase 1: Subject \< 18 years of age and weighs ≥ 6 kg at the time of signing the informed consent form (ICF)/informed assent form (IAF). Phase 2: Subject ≤ 25 years of age and weighs ≥ 6 kg at the time of signing the ICF/IAF. 2. Subject (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures. 3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements. 4. Investigator considers the subject is appropriate for adoptive T cell therapy. 5. Evidence of CD19 expression via flow cytometry (peripheral blood or bone marrow) or immunohistochemistry (bone marrow biopsy) 6. Subject has a Karnofsky score of ≥ 50 (subjects ≥ 16 years of age) or a Lansky score ≥ 50 (subjects \< 16 years of age). 7. Diagnosis of B-cell ALL or B-cell NHL as defined below: Phase 1: Subjects with r/r B-ALL, defined as morphological evidence of disease in BM (5% or greater lymphoblast by morphology) and either of the following: * First or greater marrow relapse, or * Any marrow relapse after allogeneic HSCT, or * Primary refractory defined as not achieving a CR or a CRi after 2 or more separate induction regimens (or chemo-refractory as not achieving CR/CRi after 1 cycle of standard chemotherapy for relapsed leukemia), or * Ineligible for allogeneic HSCT Note: Subjects will be included regardless of MRD status. Phase 2: Subjects with one of the following: * Cohort 1: r/r B-ALL, defined as morphological evidence of disease in BM (5% or greater lymphoblast by morphology) and either: * First or greater marrow relapse, or * Any marrow relapse after allogeneic HSCT, or * Primary refractory defined as not achieving a CR or a CRi after 2 or more separate induction regimens (or chemo-refractory as not achieving CR/CRi after 1 cycle of standard chemotherapy for relapsed leukemia), or * Ineligible for allogeneic HSCT. * Cohort 2: MRD+ B-ALL, defined as: * \< 5% lymphoblasts by morphology with, * MRD detected by a validated assay at a frequency of 1 x10-4 or greater in BM cells. Subjects eligible for enrollment in Cohort 2 are those with MRD positive morphologic CR2 after re-induction when these subjects had previously experienced an early relapse (\< 36 months) after first-line chemotherapy. Subjects who are in MRD+ morphologic CR3 and later, regardless of time to relapse in earlier lines, are also eligible. Subjects who are in morphologic relapse at screening (r/r B-ALL) and become MRD+ after bridging chemotherapy are also eligible for treatment in Cohort 2. * Cohort 3: r/r B-NHL (DLBCL, BL or PMBCL), defined as measurable disease after 1 or more lines of chemotherapy and/or having failed HSCT or being ineligible for HSCT. Note: B-NHL subjects with secondary CNS lymphoma involvement are eligible however subject selection must consider clinical risk factors for severe neurological AEs and alternative treatment options. Subjects should only be enrolled if the Investigator considers the potential benefit outweighs the risk for the subject. 8. Subjects with Philadelphia chromosome positive ALL are eligible if they are intolerant to or have failed one or more lines of tyrosine-kinase inhibitor (TKI) therapy or if TKI therapy is contraindicated. 9. Adequate organ function, defined as: * Adequate BM function to receive LD chemotherapy as assessed by the Investigator. * Subject with adequate renal function, which is defined as: Serum creatinine based on age/gender as described below. Subjects that do not meet the criteria but who have a creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 70 mL/min/1.73 m2 are eligible.• Alanine aminotransferase (ALT) ≤ 5 x upper limit of normal (ULN) and total bilirubin \< 2.0 mg/dL (or \< 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic/lymphomatous infiltration of the liver). * Adequate pulmonary function, defined as ≤ Grade 1 dyspnea according to Common Toxicity Criteria for Adverse Events (CTCAE) and oxygen saturation (SaO2) ≥ 92% on room air. * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) within 4 weeks prior to leukapheresis. 10. Adequate vascular access for leukapheresis procedure. 11. Participants must agree to use effective contraception Exclusion Criteria: The presence of any of the following will exclude a subject from enrollment: 1. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 2. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 3. Subject has any condition that confounds the ability to interpret data from the study. 4. Subject with a history of another primary malignancy that has not been in remission for at least 2 years prior to enrollment. 5. Subjects who have received previous CD19-targeted therapy must have CD19-positive disease confirmed since completing the prior CD19-targeted therapy. 6. Prior CAR T cell or other genetically-modified T cell therapy. 7. Subject with a previous history of or active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. 8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment at the time of leukapheresis or JCAR017 infusion. 9. Subject has presence of acute or chronic graft-versus-host disease (GVHD). 10. Subject with active autoimmune disease requiring immunosuppressive therapy. 11. Subject has cardiac disorders (CTCAE version 4.03 Grade 3 or 4) within the past 6 months. 12. Subject with a concomitant genetic syndrome, with the exception of Down's syndrome. 13. Subject with active CNS disease and significant neurological deterioration. Subjects with CNS-2 or CNS-3 involvement are eligible provided they are asymptomatic and do not have significant neurological deterioration and, in the opinion of the study investigator, the CNS disease burden can be controlled until JCAR017 infusion. 14. Subject with a history or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, cerebral edema, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. 15. Subject is pregnant or nursing. 16. Subject has used the following: * Therapeutic doses of corticosteroids (defined as \> 0.4 mg/kg maximum 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis or 72 hours prior to JCAR017 infusion. Physiologic replacement, topical, and inhaled steroids are permitted. * Low-dose chemotherapy (eg, vincristine, rituximab, cyclophosphamide ≤ 300 mg/m2) given after leukapheresis to maintain disease control must be stopped ≥ 7 days prior to LD chemotherapy. * Cytotoxic chemotherapeutic agents that are not considered lymphotoxic within 1 week prior to leukapheresis. Oral anticancer agents are allowed if at least 3 half-lives have elapsed prior to leukapheresis. * Lymphotoxic chemotherapeutic agents (eg, cyclophosphamide, ifosfamide, bendamustine) within 2 weeks prior to leukapheresis. * Experimental agents within 4 weeks prior to leukapheresis unless no response or PD is documented on the experimental therapy and at least 3 half-lives have elapsed prior to leukapheresis. * Immunosuppressive therapies within 4 weeks prior to leukapheresis and JCAR017 infusion (eg, calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as antitumor necrosis factor \[TNF\], anti-IL-6, or anti-IL-6R). * Donor lymphocyte infusions (DLI) within 6 weeks prior to JCAR017 infusion. * Radiation within 6 weeks prior to leukapheresis. Subjects must have PD in irradiated lesions or have additional non-irradiated lesions to be eligible. Radiation to a single lesion, if additional non-irradiated, measurable lesions are present, is allowed up to 2 weeks prior to leukapheresis. * Allogeneic HSCT within 90 days prior to leukapheresis. 17. Tumor invasion of venous or arterial vessels (B-NHL subjects only). 18. Deep Venous Thrombosis (DVT) or Pulmonary Embolism (PE) within 3 months prior to leukapheresis. Subjects with DVT or PE that occurred longer than 3 months prior to leukapheresis, who still require ongoing therapeutic levels of anti-coagulation therapy, are also excluded. 19. Existence of CD19-negative clone(s) of leukemia cells2c:Te7e,Il s'agit d'une étude de phase 1/2, ouverte, à un seul bras et multicohorte, incorporant la conception optimale en deux étapes de Simon's Optimal pour évaluer l'innocuité et l'efficacité de JCAR017 chez des sujets pédiatriques âgés de ≤ 25 ans atteints de LAL-B r/r CD19+ et de LNH-B. Au cours de la phase 1, jusqu'à 5 niveaux de dose de JCAR017 seront évalués. Le recrutement commencera chez les sujets pédiatriques atteints de LAL-B r/r au niveau de dose 1 (DL1) de 0,05 x 10^6 cellules T CAR+/kg (DL1 maximum de 5 x 10^6 cellules T CAR+ JCAR017 [non ajustées en fonction du poids]). Si cette dose est confirmée comme sûre et tolérable, des sujets supplémentaires seront recrutés à des doses plus élevées jusqu'à 0,75 x10^6 cellules T CAR+/kg (maximum de 75 x10^6 cellules T CAR+ JCAR017 [non ajustées en fonction du poids]) dans le but d'identifier le RP2D. L'escalade/désescalade de dose suivra un algorithme d'intervalle de probabilité de toxicité modifié (mTPI-2). Un comité d'examen de la sécurité (SRC) recommandera la dose de phase 2 (définie comme RP2D) sur la base d'une évaluation intégrée de la sécurité, de la pharmacocinétique et des informations préliminaires sur l'efficacité d'au moins 10 sujets pédiatriques traités au RP2D. Au cours de la phase 2, un minimum de 71 sujets supplémentaires (< 18 ans) seront recrutés dans l'une des 3 cohortes énumérées ci-dessous. La taille de l'échantillon pour les cohortes 1 et 2 est calculée selon la conception optimale en deux étapes de Simon. Les 10 sujets pédiatriques ou plus traités au RP2D en phase 1 feront partie de la taille de l'échantillon (c'est-à-dire la cohorte 1 et la cohorte 2). Par conséquent, le protocole prévoit de traiter 81 sujets pédiatriques évaluables selon le critère d'évaluation principal en phase 2, si l'évaluation des résultats à la fin de la première étape de l'étude dans chaque cohorte le justifie. Cohorte 1 (LAL-B r/r) : 48 sujets pédiatriques évaluables (13 sujets en phase 1 et 35 en phase 2) Cohorte 2 (MRD+ LAL-B) : 23 sujets pédiatriques évaluables (9 sujets en phase 1 et 14 sujets en phase 2) Cohorte 3 (LNH-B r/r [DLBCL, BL ou PMBCL]) : 10 sujets pédiatriques évaluables. En raison du taux d'incidence très faible et donc du faible nombre de sujets attendu, il n'y a pas de taille d'échantillon formelle pour ce groupe. Jusqu'à 20 sujets B-ALL supplémentaires âgés de 18 à 25 ans peuvent être inscrits à la phase 2. Après le traitement par JCAR017, les sujets entreront ensuite dans la période post-traitement pour la progression/rechute de la maladie, la sécurité, la persistance des cellules CAR T et la survie jusqu'à 24 mois après l'administration de JCAR017. L'efficacité sera évaluée à la fois localement et par un comité d'examen indépendant. Les évaluations de réponse seront basées sur des critères morphologiques de la moelle osseuse et du sang, des résultats d'examen physique, ainsi que des évaluations en laboratoire du liquide céphalo-rachidien (LCR) et des évaluations de la MRD de la moelle osseuse (B-ALL uniquement). Les sujets B-NHL subiront également une évaluation radiographique de la maladie par tomodensitométrie/IRM et biopsies tumorales, si elles sont accessibles. Le suivi post-étude pour la survie, la rechute, la toxicité à long terme et la sécurité du vecteur lentiviral se poursuivra dans le cadre d'un protocole de suivi à long terme distinct jusqu'à 15 ans après la perfusion de JCAR017 conformément aux directives réglementaires des autorités sanitaires. Un comité indépendant de surveillance des données surveillera la conduite de l’étude.19:[["$","script",null,{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"MedicalStudy\",\"name\":\"JCAR017-BCM-004\",\"url\":\"https://app.klineo.com/fr/trial/NCT03743246\",\"description\":\"Étude visant à évaluer l'innocuité et l'efficacité du JCAR017 chez des sujets pédiatriques atteints de leucémie aiguë lymphoblastique à cellules B (LAL-B) récidivante/réfractaire (r/r) et de lymphome non hodgkinien à cellules B (LNH-B) Il s'agit d'une étude de phase 1/2, ouverte, à un seul bras et m\",\"identifier\":[{\"@type\":\"PropertyValue\",\"propertyID\":\"ClinicalTrials.gov\",\"value\":\"NCT03743246\"}],\"sponsor\":[{\"@type\":\"Organization\",\"name\":\"Celgene\"}],\"healthCondition\":[{\"@type\":\"MedicalCondition\",\"name\":\"Lymphome B diffus à grandes cellules (DLBCL/LBDGC)\"},{\"@type\":\"MedicalCondition\",\"name\":\"Lymphome B primitif du médiastin (PMBL)\"},{\"@type\":\"MedicalCondition\",\"name\":\"Lymphome de Burkitt\"},{\"@type\":\"MedicalCondition\",\"name\":\"Lymphome lymphoblastique/Leucémie aiguë lymphoblastique B\"}],\"phase\":\"Phase 1/2\"}"}}],["$","$L29",null,{"trial":{"id":"3e5095f6-d1c9-416f-8e7b-a439ba007793","nctId":"NCT03743246","euctId":null,"aactOfficialTitle":"A Phase 1/2, Open-label, Single Arm, Multicohort, Multicenter Trial to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL).","aactBriefSummary":"This is a Phase 1/2, open-label, single arm, multicohort study to evaluate the safety and efficacy of JCAR017 in pediatric subjects aged ≤ 25 years with CD19+ r/r B-ALL and B-NHL.\n\nPhase 1 will identify a recommended Phase 2 dose (RP2D). Phase 2 will evaluate the efficacy of JCAR017 RP2D in the following three disease cohorts: Cohort 1 (r/r B-ALL), Cohort 2 (MRD+ B-ALL) and Cohort 3 (r/r B-NHL, \\[DLBCL, BL, or PMBCL\\]). A Simon's Optimal two-stage study design will be applied to Cohort 1 and 2 in Phase 2.","aactDescription":"$2a","aactCriteria":"$2b","aactAcronym":"JCAR017-BCM-004","aactBriefTitle":"A Study to Evaluate the Safety and Efficacy of JCAR017 in Pediatric Subjects With Relapsed/Refractory (r/r) B-cell Acute Lymphoblastic Leukemia (B-ALL) and B-cell Non-Hodgkin Lymphoma (B-NHL)","trialCriterias":[{"id":"5cae1cc8-1b8c-4d91-b30f-7f7d68855db7","type":"EXCLUSION","category":null,"shortDescription":"","description":"Le sujet présente un problème médical important, une anomalie de laboratoire ou une maladie psychiatrique qui l’empêcherait de participer à l’étude.","isImportant":false},{"id":"9d8ba71c-6a33-43e8-a773-ee723a08be68","type":"INCLUSION","category":"AGE","shortDescription":"Phase 1 : Sujet < 18 ans et pèse ≥ 6 kg","description":"Phase 1 : Sujet < 18 ans et pesant ≥ 6 kg au moment de la signature du formulaire de consentement éclairé (FCE)/formulaire d’assentiment éclairé (FAI).","isImportant":true},{"id":"c4546fc6-b21a-4875-81b4-045f50701081","type":"EXCLUSION","category":null,"shortDescription":"","description":"Le sujet présente une condition quelconque, y compris la présence d’anomalies de laboratoire, qui le place dans une situation de risque inacceptable s’il devait participer à l’étude.","isImportant":false},{"id":"42de9081-5bb0-4f0a-b435-8572aa923a49","type":"INCLUSION","category":"AGE","shortDescription":"Phase 2 : Sujet ≤ 25 ans et pèse ≥ 6 kg","description":"Phase 2 : Sujet ≤ 25 ans et pesant ≥ 6 kg au moment de la signature de l'ICF/IAF.","isImportant":true},{"id":"e1adc56c-dcf9-4c8c-82d3-ed29e6b7033f","type":"INCLUSION","category":null,"shortDescription":"","description":"Le sujet (le cas échéant, le représentant parental/légal) doit comprendre et donner volontairement son autorisation à l'ICF/IAF avant de procéder à toute évaluation/procédure liée à l'étude.","isImportant":false},{"id":"a0067fd9-224d-4622-af98-45700e7bd792","type":"EXCLUSION","category":null,"shortDescription":"","description":"Le sujet présente une condition qui rend difficile l’interprétation des données de l’étude.","isImportant":false},{"id":"ae424d2c-c705-4d79-ac65-1bbff864e546","type":"INCLUSION","category":null,"shortDescription":"","description":"Le sujet est disposé et capable de respecter le calendrier des visites d’étude et les autres exigences du protocole.","isImportant":false},{"id":"d827d9f7-2cd7-49b9-b869-eb775bd43c70","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujet ayant des antécédents d’une autre tumeur maligne primaire qui n’a pas été en rémission depuis au moins 2 ans avant l’inscription.","isImportant":false},{"id":"ff4aaac9-99bb-4ce3-b6bb-8bb9f67d0155","type":"EXCLUSION","category":"BIOMARKER_ALTERATION","shortDescription":"Les sujets qui ont déjà reçu un traitement ciblant les CD19 doivent avoir une maladie CD19 positive confirmée depuis la fin du traitement antérieur ciblé sur les CD19.","description":"Les sujets ayant reçu un traitement antérieur ciblant le CD19 doivent avoir une maladie CD19-positive confirmée depuis la fin du traitement antérieur ciblant le CD19.","isImportant":true},{"id":"d43d234b-9094-416f-9176-d23f1dcbbc14","type":"INCLUSION","category":null,"shortDescription":"","description":"L'investigateur considère que le sujet est apte à bénéficier d'une thérapie adoptive par cellules T.","isImportant":false},{"id":"69701386-4c0e-43ef-baf1-c6644d180843","type":"INCLUSION","category":"BIOMARKER_ALTERATION","shortDescription":"Preuve de l'expression de CD19 par cytométrie en flux ou immunohistochimie","description":"Preuve de l'expression du CD19 par cytométrie de flux (sang périphérique ou moelle osseuse) ou immunohistochimie (biopsie de moelle osseuse)","isImportant":true},{"id":"e94684e1-7639-4c7f-af58-46011356ece2","type":"EXCLUSION","category":null,"shortDescription":"","description":"Thérapie antérieure par cellules CAR-T ou autres cellules T génétiquement modifiées.","isImportant":false},{"id":"3d740058-e943-4fb0-86cc-62ec1a4fe22e","type":"INCLUSION","category":null,"shortDescription":"","description":"Le sujet a un score de Karnofsky ≥ 50 (sujets ≥ 16 ans) ou un score de Lansky ≥ 50 (sujets < 16 ans).","isImportant":false},{"id":"578a5752-5d89-4900-a656-8522b48d9c92","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujet ayant des antécédents d’hépatite B ou d’hépatite C active ou d’infection par le virus de l’immunodéficience humaine (VIH).","isImportant":false},{"id":"22680a70-a2f9-477f-aa3f-2401f30cfcc7","type":"INCLUSION","category":null,"shortDescription":"","description":"Première ou plus grande récidive médullaire, ou","isImportant":false},{"id":"786150bc-c390-48b9-843d-d51c0390a5c7","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujets atteints d'une infection systémique fongique, bactérienne, virale ou autre non contrôlée (y compris la tuberculose) malgré des antibiotiques appropriés ou un autre traitement au moment de la leucaphérèse ou de la perfusion de JCAR017.","isImportant":false},{"id":"3ed6e776-8af5-4e9e-a90e-d5d747146606","type":"INCLUSION","category":null,"shortDescription":"","description":"Toute récidive médullaire après une greffe de cellules souches hématopoïétiques allogéniques, ou","isImportant":false},{"id":"947a7fc7-4669-4b5b-908c-9819f1ba02fb","type":"EXCLUSION","category":null,"shortDescription":"","description":"Le sujet présente une maladie du greffon contre l’hôte (GVHD) aiguë ou chronique.","isImportant":false},{"id":"8f8dc631-77b9-497e-9c0c-21797d8b7096","type":"INCLUSION","category":null,"shortDescription":"","description":"Réfractaire primaire défini comme n'obtenant pas de CR ou de CRi après 2 ou plusieurs protocoles d'induction distincts (ou chimio-réfractaire comme n'obtenant pas de CR/CRi après 1 cycle de chimiothérapie standard pour une leucémie récidivante), ou","isImportant":false},{"id":"105c45da-8c8f-4205-bb1f-7b2da67d3036","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujet atteint d'une maladie auto-immune active nécessitant un traitement immunosuppresseur.","isImportant":false},{"id":"a87ef058-0f0c-4c4f-a70e-897f3b4c7f29","type":"INCLUSION","category":null,"shortDescription":"","description":"Non éligibles à la greffe de cellules souches hématopoïétiques allogéniques. Remarque : les sujets seront inclus quel que soit leur statut de MRD.","isImportant":false},{"id":"7722e9c6-052b-4eca-a985-92c44d1910d4","type":"EXCLUSION","category":null,"shortDescription":"","description":"Le sujet présente des troubles cardiaques (CTCAE version 4.03 Grade 3 ou 4) au cours des 6 derniers mois.","isImportant":false},{"id":"4477991e-09af-49e3-80b6-26bc15167f2e","type":"INCLUSION","category":null,"shortDescription":"","description":"Première ou plus grande récidive médullaire, ou","isImportant":false},{"id":"7e4f7c82-6dac-4c92-8f23-222b362f54ed","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujet présentant un syndrome génétique concomitant, à l'exception du syndrome de Down.","isImportant":false},{"id":"1ab9ad81-f9d2-4340-a69a-316e1edefc5e","type":"INCLUSION","category":null,"shortDescription":"","description":"Toute récidive médullaire après une greffe de cellules souches hématopoïétiques allogéniques, ou","isImportant":false},{"id":"dfcefbab-a2f5-42cb-b12f-82a5d6f99e33","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujet présentant une maladie active du SNC et une détérioration neurologique significative. Les sujets présentant une atteinte du SNC-2 ou du SNC-3 sont éligibles à condition qu'ils soient asymptomatiques et ne présentent pas de détérioration neurologique significative et que, de l'avis de l'investigateur de l'étude, la charge de morbidité du SNC puisse être contrôlée jusqu'à la perfusion de JCAR017.","isImportant":false},{"id":"277994cb-6503-4d2e-8efc-3f8f7e8e7086","type":"EXCLUSION","category":null,"shortDescription":"","description":"Sujet ayant des antécédents ou présence d'une pathologie du SNC cliniquement pertinente telle qu'épilepsie, crise, parésie, aphasie, accident vasculaire cérébral, œdème cérébral, lésions cérébrales graves, démence, maladie de Parkinson, maladie cérébelleuse, syndrome cérébral organique ou psychose.","isImportant":false},{"id":"9d8fec63-824a-4e1f-8770-768c1777b640","type":"INCLUSION","category":null,"shortDescription":"","description":"Réfractaire primaire défini comme n'obtenant pas de CR ou de CRi après 2 ou plusieurs protocoles d'induction distincts (ou chimio-réfractaire comme n'obtenant pas de CR/CRi après 1 cycle de chimiothérapie standard pour une leucémie récidivante), ou","isImportant":false},{"id":"07f2cb3a-9983-4983-bfc3-2759227ba148","type":"INCLUSION","category":null,"shortDescription":"","description":"Non éligible à la greffe de cellules souches hématopoïétiques allogéniques.","isImportant":false},{"id":"a2efd696-7b97-4597-acb2-c79897f25914","type":"EXCLUSION","category":null,"shortDescription":"","description":"Le sujet est enceinte ou allaite.","isImportant":false},{"id":"b6d8c995-8db7-451b-98b1-5001066e7711","type":"EXCLUSION","category":null,"shortDescription":"","description":"Doses thérapeutiques de corticostéroïdes (définies comme > 0,4 mg/kg maximum 20 mg/jour de prednisone ou équivalent) dans les 7 jours précédant la leucaphérèse ou 72 heures précédant la perfusion de JCAR017. Les stéroïdes de substitution physiologique, topiques et inhalés sont autorisés.","isImportant":false},{"id":"fe24e0fd-2045-4ed9-96f7-d6f89a5a7308","type":"INCLUSION","category":null,"shortDescription":"","description":"< 5% de lymphoblastes par morphologie avec,","isImportant":false},{"id":"0c857e93-21e7-477e-ad09-38c6f044e3b2","type":"INCLUSION","category":null,"shortDescription":"","description":"MRD détectée par un test validé à une fréquence de 1 x 10-4 ou plus dans les cellules de moelle osseuse. Les sujets éligibles à l'inscription dans la cohorte 2 sont ceux qui présentent une MRD positive CR2 morphologique après réinduction lorsque ces sujets ont déjà connu une rechute précoce (< 36 mois) après une chimiothérapie de première intention. Les sujets qui sont en MRD+ CR3 morphologique et plus, quel que soit le délai de rechute dans les lignes précédentes, sont également éligibles au traitement dans la cohorte 2. Les sujets qui sont en rechute morphologique au moment de la sélection (r/r B-ALL) et deviennent MRD+ après une chimiothérapie de transition sont également éligibles au traitement dans la cohorte 2.","isImportant":false},{"id":"c0ab474e-749d-4d4e-abae-e3fc032f35cc","type":"EXCLUSION","category":null,"shortDescription":"","description":"La chimiothérapie à faible dose (par exemple, vincristine, rituximab, cyclophosphamide ≤ 300 mg/m2) administrée après la leucaphérèse pour maintenir le contrôle de la maladie doit être arrêtée ≥ 7 jours avant la chimiothérapie à faible dose.","isImportant":false},{"id":"7ac4ef09-1c7e-463a-97c3-2f073ab31b03","type":"EXCLUSION","category":null,"shortDescription":"","description":"Agents chimiothérapeutiques cytotoxiques qui ne sont pas considérés comme lymphotoxiques dans la semaine précédant la leucaphérèse. Les agents anticancéreux oraux sont autorisés si au moins 3 demi-vies se sont écoulées avant la leucaphérèse.","isImportant":false},{"id":"98b3ccca-1d04-4c4f-8705-7d56b6e95c48","type":"INCLUSION","category":null,"shortDescription":"","description":"Cohorte 3 : LNH-B r/r (DLBCL, BL ou PMBCL), défini comme une maladie mesurable après 1 ou plusieurs lignes de chimiothérapie et/ou ayant échoué à la greffe de cellules souches hématopoïétiques (GCSH) ou étant inéligible à la greffe de cellules souches hématopoïétiques (GCSH).","isImportant":false},{"id":"08715f06-4267-48ad-bd68-dcf2182a513b","type":"INCLUSION","category":null,"shortDescription":"","description":"Remarque : les sujets atteints de LNH-B avec atteinte secondaire du SNC par un lymphome sont éligibles. Cependant, la sélection des sujets doit tenir compte des facteurs de risque cliniques d'effets indésirables neurologiques graves et des options de traitement alternatives. Les sujets ne doivent être recrutés que si l'investigateur considère que le bénéfice potentiel l'emporte sur le risque pour le sujet.","isImportant":false},{"id":"8a99607e-7a57-494c-ade3-822223971663","type":"EXCLUSION","category":null,"shortDescription":"","description":"Agents chimiothérapeutiques lymphotoxiques (par exemple, cyclophosphamide, ifosfamide, bendamustine) dans les 2 semaines précédant la leucaphérèse.","isImportant":false},{"id":"67260832-7f0a-436a-87c8-a76001ffcb82","type":"EXCLUSION","category":null,"shortDescription":"","description":"Agents expérimentaux dans les 4 semaines précédant la leucaphérèse, sauf si aucune réponse ou PD n'est documentée sur la thérapie expérimentale et qu'au moins 3 demi-vies se sont écoulées avant la leucaphérèse.","isImportant":false},{"id":"1b1e1432-3ccf-4a4b-a96c-fd2fbd293c4a","type":"INCLUSION","category":null,"shortDescription":"","description":"Les sujets atteints de LAL à chromosome Philadelphie positif sont éligibles s'ils sont intolérants ou ont échoué à une ou plusieurs lignes de traitement par inhibiteur de la tyrosine kinase (ITK) ou si le traitement par ITK est contre-indiqué.","isImportant":false},{"id":"aabd4531-e494-449c-b089-943be143b318","type":"INCLUSION","category":null,"shortDescription":"","description":"Fonction BM adéquate pour recevoir une chimiothérapie LD telle qu'évaluée par l'investigateur.","isImportant":false},{"id":"fb175155-9005-460e-a3da-d7082cd70c60","type":"EXCLUSION","category":null,"shortDescription":"","description":"Thérapies immunosuppressives dans les 4 semaines précédant la leucaphérèse et la perfusion de JCAR017 (par exemple, inhibiteurs de la calcineurine, méthotrexate ou autres chimiothérapies, mycophénolate, rapamycine, thalidomide, anticorps immunosuppresseurs tels que le facteur de nécrose tumorale [TNF], anti-IL-6 ou anti-IL-6R).","isImportant":false},{"id":"e37eb74b-894e-4d1a-8bd8-d02dc6a3d453","type":"INCLUSION","category":null,"shortDescription":"","description":"Créatinine sérique en fonction de l'âge/du sexe, comme décrit ci-dessous. Les sujets qui ne répondent pas aux critères mais qui ont une clairance de la créatinine ou un débit de filtration glomérulaire radio-isotopique (DFG) > 70 mL/min/1,73 m2 sont éligibles.• Alanine aminotransférase (ALAT) ≤ 5 x limite supérieure de la normale (LSN) et bilirubine totale < 2,0 mg/dL (ou < 3,0 mg/dL pour les sujets atteints du syndrome de Gilbert ou d'infiltration leucémique/lymphomateuse du foie).","isImportant":false},{"id":"e0618f0a-5bea-4e28-bd4f-4751f8bb3366","type":"EXCLUSION","category":null,"shortDescription":"","description":"Infusions de lymphocytes de donneur (DLI) dans les 6 semaines précédant la perfusion de JCAR017.","isImportant":false},{"id":"64ba1f8f-c294-46c1-83ab-d305fbf7b5ec","type":"INCLUSION","category":null,"shortDescription":"","description":"Fonction pulmonaire adéquate, définie comme une dyspnée ≤ grade 1 selon les critères communs de toxicité pour les événements indésirables (CTCAE) et une saturation en oxygène (SaO2) ≥ 92 % à l'air ambiant.","isImportant":false},{"id":"ae0702f7-f3a9-46a5-875a-b08ae391b3df","type":"EXCLUSION","category":null,"shortDescription":"","description":"Radiothérapie dans les 6 semaines précédant la leucaphérèse. Les sujets doivent présenter une MP dans des lésions irradiées ou présenter des lésions supplémentaires non irradiées pour être éligibles. La radiothérapie d'une seule lésion, si des lésions supplémentaires non irradiées et mesurables sont présentes, est autorisée jusqu'à 2 semaines avant la leucaphérèse.","isImportant":false},{"id":"bd368eb6-507e-4d7a-9e9c-86496ed8544f","type":"INCLUSION","category":null,"shortDescription":"","description":"Fonction cardiaque adéquate, définie comme une fraction d'éjection ventriculaire gauche (FEVG) ≥ 40 % évaluée par échocardiogramme (ECHO) ou scintigraphie à acquisition multi-synchronisée (MUGA) dans les 4 semaines précédant la leucaphérèse.","isImportant":false},{"id":"969163f0-d29c-4227-ac5f-0367f195daf6","type":"EXCLUSION","category":null,"shortDescription":"","description":"Greffe hématopoïétique allogénique dans les 90 jours précédant la leucaphérèse.","isImportant":false},{"id":"22eb5c76-c420-4205-a970-91b556392819","type":"EXCLUSION","category":null,"shortDescription":"","description":"Invasion tumorale des vaisseaux veineux ou artériels (sujets B-NHL uniquement).","isImportant":false},{"id":"e7f86224-be65-4d6b-92a2-95dfb083fd08","type":"INCLUSION","category":null,"shortDescription":"","description":"Accès vasculaire adéquat pour la procédure de leucaphérèse.","isImportant":false},{"id":"ec5bf8af-b27a-468c-b8a1-2f48a42a0543","type":"EXCLUSION","category":null,"shortDescription":"","description":"Thrombose veineuse profonde (TVP) ou embolie pulmonaire (EP) survenue dans les 3 mois précédant la leucaphérèse. Les sujets atteints de TVP ou d'EP survenues plus de 3 mois avant la leucaphérèse et qui nécessitent toujours des niveaux thérapeutiques continus de traitement anticoagulant sont également exclus.","isImportant":false},{"id":"138db9d0-21ce-4e75-8b70-07b7c063893f","type":"INCLUSION","category":null,"shortDescription":"","description":"Les participants doivent accepter d'utiliser une contraception efficace","isImportant":false},{"id":"70d00124-c6fc-48fb-b117-448f3d6cd70f","type":"EXCLUSION","category":null,"shortDescription":"","description":"Existence de clones CD19-négatifs de cellules leucémiques","isImportant":false}],"trialMetadata":{"acronym":"JCAR017-BCM-004","id":"90dc54f9-2991-4d00-be17-c5abc140ca01","studyType":"INTERVENTIONAL_THERAPEUTIC","areCohortsConfidential":false,"briefTitle":"Étude visant à évaluer l'innocuité et l'efficacité du JCAR017 chez des sujets pédiatriques atteints de leucémie aiguë lymphoblastique à cellules B (LAL-B) récidivante/réfractaire (r/r) et de lymphome non hodgkinien à cellules B (LNH-B)","officialTitle":"Essai de phase 1/2, ouvert, à bras unique, multicohorte et multicentrique visant à évaluer l'innocuité et l'efficacité de JCAR017 chez des sujets pédiatriques atteints de leucémie aiguë lymphoblastique à cellules B (LAL-B) récidivante/réfractaire (r/r) et de lymphome non hodgkinien à cellules B (LNH-B).","klineoTitle":"Une étude pour évaluer la tolérance et l'efficacité du JCAR017 chez des sujets pédiatriques atteints de leucémie lymphoblastique aiguë à cellules B en rechute/réfractaire (r/r) (LAL-B) et de lymphome non hodgkinien à cellules B (LNH-B)","briefSummary":"Il s'agit d'une étude de phase 1/2, ouverte, à un seul bras et multicohorte visant à évaluer l'innocuité et l'efficacité de JCAR017 chez des sujets pédiatriques âgés de ≤ 25 ans atteints de LAL-B r/r CD19+ et de LNH-B.\n\nLa phase 1 permettra d'identifier une dose recommandée pour la phase 2 (RP2D). La phase 2 évaluera l'efficacité de JCAR017 RP2D dans les trois cohortes de maladies suivantes : cohorte 1 (LAL-B r/r), cohorte 2 (LAL-B MRD+) et cohorte 3 (LNH-B r/r, [DLBCL, BL ou PMBCL]). Une conception d'étude optimale de Simon en deux étapes sera appliquée aux cohortes 1 et 2 de la phase 2.","description":"$2c","partnerDescriptionUrl":"https://www.orely.org/essais-cliniques/1657127061/lymphomes-indolents-en-rechute-ou-refractaire-phase-2---evaluation-d-un-traitement-par-cellules-car-t-jcar017-lisocabtagene-maraleucel.html","maximumAge":25,"maximumLines":null,"minimumAge":null,"minimumLines":2,"brainJustification":"","isLlmMatchingVisible":false,"sponsors":[{"name":"Celgene"}],"medicalMetadata":{"id":"150bd1a2-4f96-492e-9f4c-804cf541cc40","phase":"ONE_MIDTERM_TWO","oms":2,"recistMeasurable":"YES","brainMetastasis":null,"situations":[],"histologies":[{"id":"c8fbd4b7-9500-4559-9860-e74a09876837","name":"Lymphome B diffus à grandes cellules (DLBCL/LBDGC)","slug":"Diffuse large b-cell lymphoma"},{"id":"12aacc4b-bd9d-433c-a6b8-027816e0dc99","name":"Lymphome B primitif du médiastin (PMBL)","slug":"Primary mediastinal large B-cell 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