ALL-REZ Beobachtungsstudie

By recording all children and adolescents with an ALL recurrence as completely as possible in a register, epidemiological statements can be made about the incidence, course and prognosis of children with ALL recurrence. This group contributes more than any other to the mortality of children with malignant diseases. Patients can be systematically followed up, late effects recorded and correlated with previous therapies and clinical factors. Corresponding risks can be taken into account in future therapy strategies. As a competence centre for relapsed/refractory ALL, the study centre can advise participating centres on specific questions regarding individual therapy strategies as well as radiation and transplantation indications. Patients with relapsed and/or refractory ALL can be counselled regarding treatment in an open AMG study and assigned accordingly. The treatment instructions enclosed with this protocol do not represent recommendations for a generally recognised treatment in this specific form and combination, but are rather guidelines for treatment. The risk groups S1 to S4 are categorised according to the definition of the ALL-REZ BFM 2002 study. The only change to this classification is the categorisation of very early isolated extramedullary recurrences in the S4 group. Due to the good results of the ALL-REZ BFM 2002 study, treatment according to the ALL-REZ BFM 2002 protocol is still recommended for children and adolescents with first ALL recurrence until the start of the new international ALL recurrence study. Consolidation is carried out with protocol II-Ida. In the event of a subsequent relapse, consultation with the study centre is recommended.

{ "short_title": "ALL-REZ Beobachtungsstudie", "data_mode": "900", "data_mode_number": "000002448", "official_title": "ALL-REZ BFM-Beobachtungsstudie und Biobank f\u00fcr Rezidive einer akuten lymphoblastischen Leuk\u00e4mie im Kindes- und Jugendalter", "accrual_state": "running", "therapeutic_value": null, "therapieansatz_value": "kurativ", "therapieintervention_value": null, "therapielinie_value": null, "ctgov_number": null, "eudract_number": null, "general_contact_email": "Kik-dokuteam-hs65@ukdd.de", "general_contact_phone": "+49 351-4585035", "hauptpruefer_dd_name": "Tobias D\u00e4britz", "description_laie_de": "Durch die m\u00f6glichst vollst\u00e4ndige Erfassung aller Kinder und Jugendlichen mit einem ALL-Rezidiv in einem Register sind epidemiologische Aussagen \u00fcber Inzidenz, Verlauf und Prognose von Kindern mit ALL-Rezidiv m\u00f6glich. Diese Gruppe tr\u00e4gt wie keine andere zur Sterblichkeit von Kindern mit b\u00f6sartigen Erkrankungen bei. Patienten k\u00f6nnen systematisch nachbeobachtet, Sp\u00e4tfolgen erfasst und mit vorangegangenen Therapien und klinischen Faktoren korreliert werden. Entsprechende Risiken k\u00f6nnen in zuk\u00fcnftigen Therapiestrategien ber\u00fccksichtigt werden. Als Kompetenzzentrum f\u00fcr rezidivierte/refrakt\u00e4re ALL kann die Studienzentrale teilnehmende Zentren in speziellen Fragestellungen hinsichtlich individueller Therapiestrategien sowie Bestrahlungs- und Transplantationsindikationen beraten. Patienten mit rezidivierter und/oder refrakt\u00e4rer ALL k\u00f6nnen hinsichtlich der Behandlung in einer offenen AMG-Studie beraten und entsprechend zugewiesen werden.\r\n\t\r\nDie diesem Protokoll beiliegenden Therapieanweisungen stellen in der vorliegenden speziellen Form und Kombination keine Empfehlungen f\u00fcr eine allgemein anerkannte Behandlung dar, sondern sind vielmehr Richtlinien f\u00fcr eine Behandlung.\r\nDie Risikogruppen S1 bis S4 werden gem\u00e4\u00df der Definition der Studie ALL-REZ BFM 2002 eingeteilt. Die einzige \u00c4nderung dieser Einteilung liegt in der Einordnung der sehr fr\u00fchen isoliert extramedull\u00e4ren Rezidive in die S4-Gruppe. Aufgrund der guten Ergebnisse der Studie ALL-REZ BFM 2002 wird f\u00fcr Kinder und Jugendliche mit erstem ALL-Rezidiv weiterhin eine Behandlung gem\u00e4\u00df des Protokolls ALL-REZ BFM 2002 empfohlen, bis zum Beginn der neuen internationalen ALL-Rezidiv-Studie. Die Konsolidierung wird mit Protokoll II-Ida durchgef\u00fchrt. Im Falle eines Folgerezidivs wird die R\u00fccksprache mit der Studienzentrale empfohlen.", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "By recording all children and adolescents with an ALL recurrence as completely as possible in a register, epidemiological statements can be made about the incidence, course and prognosis of children with ALL recurrence. This group contributes more than any other to the mortality of children with malignant diseases. Patients can be systematically followed up, late effects recorded and correlated with previous therapies and clinical factors. Corresponding risks can be taken into account in future therapy strategies. As a competence centre for relapsed/refractory ALL, the study centre can advise participating centres on specific questions regarding individual therapy strategies as well as radiation and transplantation indications. Patients with relapsed and/or refractory ALL can be counselled regarding treatment in an open AMG study and assigned accordingly.\r\n\r\nThe treatment instructions enclosed with this protocol do not represent recommendations for a generally recognised treatment in this specific form and combination, but are rather guidelines for treatment.\r\nThe risk groups S1 to S4 are categorised according to the definition of the ALL-REZ BFM 2002 study. The only change to this classification is the categorisation of very early isolated extramedullary recurrences in the S4 group. Due to the good results of the ALL-REZ BFM 2002 study, treatment according to the ALL-REZ BFM 2002 protocol is still recommended for children and adolescents with first ALL recurrence until the start of the new international ALL recurrence study. Consolidation is carried out with protocol II-Ida. In the event of a subsequent relapse, consultation with the study centre is recommended.", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 14, "sub_cat_id": 66 }

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