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Barmherzigen Brüder","54292",{"type":79,"coordinates":738},[731,732],{"lat":732,"lon":731},{"facility":741,"status":73,"city":742,"state":40,"zip":743,"country":76,"countryCode":77,"cosmosGeoPoint":744,"geoPoint":748,"contacts":40},"Universitätsklinikum Tübingen","Tübingen","72076",{"type":79,"coordinates":745},[746,747],9.05222,48.52266,{"lat":747,"lon":746},{"facility":750,"status":73,"city":751,"state":40,"zip":752,"country":76,"countryCode":77,"cosmosGeoPoint":753,"geoPoint":757,"contacts":40},"Universitätsklinikum Ulm","Ulm","89081",{"type":79,"coordinates":754},[755,756],9.99155,48.39841,{"lat":756,"lon":755},{"facility":759,"status":73,"city":760,"state":40,"zip":761,"country":76,"countryCode":77,"cosmosGeoPoint":762,"geoPoint":766,"contacts":40},"Klinikum Schwarzwald-Baar","Villingen-Schwenningen","78052",{"type":79,"coordinates":763},[764,765],8.49358,48.06226,{"lat":765,"lon":764},{"facility":768,"status":73,"city":769,"state":40,"zip":770,"country":76,"countryCode":77,"cosmosGeoPoint":771,"geoPoint":775,"contacts":40},"Helios Klinikum Wuppertal","Wuppertal","42283",{"type":79,"coordinates":772},[773,774],7.14816,51.25627,{"lat":774,"lon":773},{"facility":777,"status":73,"city":778,"state":40,"zip":779,"country":76,"countryCode":77,"cosmosGeoPoint":780,"geoPoint":784,"contacts":40},"Universitätsklinikum Würzburg","Würzburg","97080",{"type":79,"coordinates":781},[782,783],9.95121,49.79391,{"lat":783,"lon":782},{"facility":786,"status":73,"city":787,"state":40,"zip":788,"country":76,"countryCode":77,"cosmosGeoPoint":789,"geoPoint":793,"contacts":40},"Heinrich-Braun Klinikum","Zwickau","08060",{"type":79,"coordinates":790},[791,792],12.48839,50.72724,{"lat":792,"lon":791},{"type":57,"investigatorFullName":795,"investigatorTitle":796,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"Nicola Goekbuget","Dr. Nicola Gökbuget",[798,801],{"name":799,"class":800},"Deutsche Leukämie- & Lymphom-Hilfe","UNKNOWN",{"name":802,"class":803},"German Federal Ministry of Education and Research","OTHER_GOV","100520786","phase-2-randomized-trial-in-adult-de-novo-ph-positive-all-with-chemotherapy-imatinib-or-ponatinib-blinatumomab-and-sct-100520786",false,"NCT06061094","Randomized Trial in Adult de Novo Ph Positive ALL With Chemotherapy, Imatinib or Ponatinib, Blinatumomab and SCT","A Multicentre, Randomized Trial in Adults With de Novo Philadelphia-Chromosome Positive Acute Lymphoblastic Leukemia to Assess the Efficacy of Ponatinib Versus Imatinib in Combination With Low-intensity Chemotherapy, to Compare End of Therapy With Indication for SCT Versus TKI, Blinatumomab and Chemotherapy in Optimal Responders and to Evaluate Blinatumomab in Suboptimal Responders (GMALL-EVOLVE)","GMALL-EVOLVE","Inclusion Criteria:\n\n* Male or female patients \\>= 18 years, \\\u003C=65 years\n* Philadelphia chromosome or BCR-ABL1 positive ALL\n* Not previously treated except with corticosteroids ≤ 7 days, standard GMALL prephase with dexamethasone and cyclophosphamide including intrathecal therapy, hydroxyurea, a single dose vincristine or other cytostatic drugs and start of standard induction for Ph-positive ALL (1 dose vincristine, 1 dose of Rituximab, 2 doses dexamethasone and up to 5 days Imatinib)\n* ECOG performance status ≤2\n* Signed written inform consent\n* Molecular evaluation for BCR-ABL1 performed\n* Negative pregnancy test in women of childbearing potential\n* Woman of childbearing potential willing to use 2 highly effective methods of contraception while receiving study treatment and for an additional 3 months after the last dose of study treatment (Pearl-Index \\\u003C1%). Male who has a female partner of childbearing potential willing to use 2 highly effective forms of contraception while receiving study treatment and for at least an additional 3 months after the last dose of study treatment (Pearl-Index \\\u003C1%).\n* Normal serum levels \\> LLN (lower limit of normal) of potassium and magnesium, or corrected to within normal limits with supplements, prior to the first dose of study medication\n* Serum lipase ≤ 1.5 x ULN. For serum lipase \\> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis\n* Normal QTcF interval ≤450 ms for males and ≤470 ms for females\n* Signed and dated written informed consent is available\n* Participation in the registry of the German Multicenter Study Group for Adult ALL (GMALL)\n\nExclusion Criteria:\n\n* History of malignancy other than ALL diagnosed within 5 years (yrs) prior to start of protocol-specified therapy with defined exceptions\n* Contraindications against the use of Imatinib, Ponatinib, chemotherapy or Blinatumomab\n* Patient previously treated with tyrosine kinase inhibitors\n* Nursing women\n* Known impaired cardiac function, including any of the following: as detailed in protocol\n* Symptomatic peripheral vascular disease\n* Any history of ischemic stroke or transient ischemic attacks (TIAs)\n* Uncontrolled hypertriglyceridaemia\n* History or presence of clinically relevant CNS pathology as detailed in protocol\n* History or active relevant autoimmune disease\n* Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) or active infection with Hepatitis B or C\n* History of pancreatitis within 6 months previous to start of treatment within the trial\n* Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study\n* Inadequate hepatic functions defined as ASAT or ALAT \\> 2,5 times the institutional upper limit of normal or \\> 5 times ULN if considered due to leukemia\n* Total bilirubin \\> 1.5-fold the institutional upper limit unless considered to be due to organ involvement by the leukemia or to M. Gilbert \u002F M. Meulengracht\n* Concurrent severe diseases which exclude the administration of therapy e.g. severe, uncontrolled acute or chronic infections\n* Inability to understand and\u002For unwillingness to sign a written informed consent","ALL","18 Years","65 Years",{"count":816,"type":817},220,"ESTIMATED","INTERVENTIONAL",[820],"PHASE2","The current Standard of Care (SoC) in younger patients with Ph+ ALL is Imatinib in combination with low-dose chemotherapy, change of TKI in case of persistent MRD above 10-3 after consolidation I and indication for stem cell transplantation.\n\nThe EVOLVE trial aims to answer three questions challenging the current SoC:\n\nUse of Ponatinib compared to Imatinib both in combination with low-dose chemotherapy and consolidation I (randomization I).\n\nIn MRD good responders: Omit end of therapy in primary care and indication for SCT but continue therapy with TKI, chemotherapy and Blinatumomab as additional antileukemic compound (randomization II).\n\nIn MRD poor responders: Omit indication for TKI change but give instead Blinatumomab followed by end of therapy in primary care and indication for SCT (non-randomized).",[823],"Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia",[823,825,46],"Tyrosinekinase Inhibitors","2025-04-25",{"date":828,"type":829},"2025-04-29","ACTUAL",{"date":831,"type":829},"2023-07-14",{"date":833,"type":817},"2029-07-01",{"name":5,"class":6},85]