LBL 2018

Primary research question Randomisation R1 (for all patients in the main study cohort): Can the cumulative incidence for recurrences with CNS involvement (CNS recurrence, pCICR) be reduced by an induction phase in which the three-week standard glucocorticoid therapy with prednisone (60mg/m²/d) plus tapering over 9 days is replaced by a 2-week dexamethasone treatment (10mg/m²/d)? Randomisation R2 (for high-risk patients in the main study cohort): For these patients, can the probability of event-free survival (pEFS) be improved by the intensified treatment arm (protocol Ib* and intensified protocol M) compared to the standard treatment arm (protocol Ib and protocol M)? Secondary research question the pEFS and the cumulative incidence of recurrence/CNS recurrence compared to the EURO-LB 02 clinical trial overall survival (OS), defined as the time from diagnosis to death (of any cause) or to the date of last contact with living patients compared to the EURO-LB 02 study treatment-related mortality in the randomised arms and in comparison to EURO-LB02 the profile of adverse events and serious adverse events in protocol-specific elements, in the randomisation arms, during follow-up and in comparison to EURO-LB02 the feasibility and results of risk stratification the identification of prognostic molecular markers for T-LBL the feasibility of evaluating minimal residual disease (MRD) in children and adolescents with LBL

{ "short_title": "LBL 2018", "data_mode": "900", "data_mode_number": "000002465", "official_title": "LBL 2018- Internationales Protokoll zur Behandlung von Kindern und Jugendlichen mit lymphoblastischen Lymphomen", "accrual_state": "running", "therapeutic_value": "therapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": null, "therapielinie_value": "first", "ctgov_number": null, "eudract_number": "2017-001691-39", "general_contact_email": "Kik-dokuteam-hs65@ukdd.de", "general_contact_phone": "+49 351-4585035", "hauptpruefer_dd_name": "Prof. Dr. med. Ralf Kn\u00f6fler", "description_laie_de": "Prim\u00e4re Fragestellung\r\nRandomisierung R1 (f\u00fcr alle Patienten der Schwerpunkt-Studienkohorte): Kann die kumulative Inzidenz f\u00fcr Rezidive mit Beteiligung des ZNS (ZNS Rezidiv, pCICR) durch eine Induktionsphase, in der die dreiw\u00f6chige Standard-Glukokortikoidtherapie mit Prednison (60mg/m\u00b2/d) plus Ausschleichen \u00fcber 9 Tage durch eine 2-w\u00f6chige Dexamethasonbehandlung (10mg/m\u00b2/d) ersetzt wird, reduziert werden?\r\nRandomisierung R2 (f\u00fcr Hochrisiko-Patienten der Schwerpunkt-Studienkohorte): Kann f\u00fcr diese Patienten die ereignisfreie \u00dcberlebenswahrscheinlichkeit (pEFS) durch den intensivierten Behandlungsarm (Protokoll Ib* und intensiviertes Protokoll M) im Vergleich zum Standard-Behandlungsarm (Protokoll Ib und Protokoll M) verbessert werden?\r\n\r\nSekund\u00e4re Fragestellung\r\ndas pEFS und die kumulative Inzidenz f\u00fcr Rezidive/ZNS-Rezidive im Vergleich zur klinischen Studie EURO-LB 02\r\ndas Gesamt\u00fcberleben (OS), definiert als Zeitraum von Diagnosestellung bis zum Tod (jeder Ursache) oder bis zum Datum des letzten Kontakts zu lebenden Patienten im Vergleich zur Studie EURO-LB 02\r\ndie therapiebedingte Mortalit\u00e4t in den randomisierten Armen und im Vergleich zu EURO-LB02\r\ndas Profil von unerw\u00fcnschten Ereignissen und schweren unerw\u00fcnschten Ereignissen in protokollspezifischen Elementen, in den Randomisierungs-Armen, w\u00e4hrend der Nachsorge und im Vergleich zu EURO-LB02\r\ndie Durchf\u00fchrbarkeit und Ergebnisse der Risikostratifizierung\r\ndie Identifikation prognostischer molekularer Marker f\u00fcr T-LBL\r\ndie Durchf\u00fchrbarkeit der Evaluation der minimalen Resterkrankung (MRD) bei Kindern und Jugendlichen mit LBL", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "Primary research question\r\nRandomisation R1 (for all patients in the main study cohort): Can the cumulative incidence for recurrences with CNS involvement (CNS recurrence, pCICR) be reduced by an induction phase in which the three-week standard glucocorticoid therapy with prednisone (60mg/m\u00b2/d) plus tapering over 9 days is replaced by a 2-week dexamethasone treatment (10mg/m\u00b2/d)?\r\nRandomisation R2 (for high-risk patients in the main study cohort): For these patients, can the probability of event-free survival (pEFS) be improved by the intensified treatment arm (protocol Ib* and intensified protocol M) compared to the standard treatment arm (protocol Ib and protocol M)?\r\n\r\nSecondary research question\r\nthe pEFS and the cumulative incidence of recurrence/CNS recurrence compared to the EURO-LB 02 clinical trial\r\noverall survival (OS), defined as the time from diagnosis to death (of any cause) or to the date of last contact with living patients compared to the EURO-LB 02 study\r\ntreatment-related mortality in the randomised arms and in comparison to EURO-LB02\r\nthe profile of adverse events and serious adverse events in protocol-specific elements, in the randomisation arms, during follow-up and in comparison to EURO-LB02\r\nthe feasibility and results of risk stratification\r\nthe identification of prognostic molecular markers for T-LBL\r\nthe feasibility of evaluating minimal residual disease (MRD) in children and adolescents with LBL", "rechtsgrundlage_value": "AMG", "phase_amg_value": "III", "main_cat_id": 14, "sub_cat_id": 65 }

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