CML-paed II Register

Patients are usually diagnosed and treated at the GPOH centres (see list) in accordance with the guidelines. Treatment is carried out within the scope of the authorisation with imatinib as well as with the now approved second-generation tyrosine kinase inhibitors, dasatinib and nilotinib. The drugs are not given on a trial basis. The patients are treated independently of the registry (before and after). There are also no disadvantages for current and future therapies as a result of the registry. Since 01.01.2016, the registry has also served to continue a therapy optimisation study closed on 31.12.2015 (follow-up completed at the end of 2020), initially based in Dresden, since the change of study management from 01.04.2018 based in Erlangen. Study arms: None

{ "short_title": "CML-paed II Register", "data_mode": "900", "data_mode_number": "000002449", "official_title": "Protokoll f\u00fcr standardisierte diagnostische Prozeduren, Registrierung und Behandlungsempfehlungen f\u00fcr Kinder und Jugendliche mit einer Philadelphia-Chromosom-positiven chronischen myeloischen Leuk\u00e4mie (CML)", "accrual_state": "running", "therapeutic_value": "nonTherapeutic", "therapieansatz_value": "kurativ", "therapieintervention_value": null, "therapielinie_value": "not_applicable", "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": "Die Patienten werden i.d.R. an den GPOH-Zentren (s. Liste) nach Leitlinie diagnostiziert und behandelt. Die Behandlung erfolgt im Rahmen der Zulassung sowohl mit Imatinib als auch mit den inzwischen zugelassenen Tyrosinkinaseinhibitoren der zweiten Generation, Dasatinib und Nilotinib. Die Medikamente werden nicht studienbedingt gegeben. Die Patienten sind unabh\u00e4ngig vom Register in Behandlung (bereits davor und danach). Es entstehen durch das Register auch keine Nachteile f\u00fcr aktuelle und zuk\u00fcnftige Therapien.\r\n\t\r\nDas Register dient seit 01.01.2016 auch der Weiterf\u00fchrung einer zum 31.12.2015 geschlossenen Therapieoptimierungsstudie (Nachbeobachtung Ende 2020 beendet), zun\u00e4chst mit Sitz in Dresden, seit Wechsel der Studienleitung ab 01.04.2018 mit Sitz in Erlangen.\r\nStudienarme: Keine", "description_laie_en": null, "description_expert_de": null, "description_expert_en": "Patients are usually diagnosed and treated at the GPOH centres (see list) in accordance with the guidelines. Treatment is carried out within the scope of the authorisation with imatinib as well as with the now approved second-generation tyrosine kinase inhibitors, dasatinib and nilotinib. The drugs are not given on a trial basis. The patients are treated independently of the registry (before and after). There are also no disadvantages for current and future therapies as a result of the registry.\r\n\t\r\nSince 01.01.2016, the registry has also served to continue a therapy optimisation study closed on 31.12.2015 (follow-up completed at the end of 2020), initially based in Dresden, since the change of study management from 01.04.2018 based in Erlangen.\r\nStudy arms: None", "rechtsgrundlage_value": "BO", "phase_amg_value": null, "main_cat_id": 14, "sub_cat_id": 66 }