Indikation: Studientitel: Leiter Ansprechpartner: klinische Prüfung: Studie zur Rekrutierung geschlossen! Studie zur Rekrutierung geschlossen!

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1 Indikation: Studientitel: Leiter klinische Prüfung: Ansprechpartner: Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leukemia exhibiting a FLT3 internal tandem duplication (SG 16-10). Studie zur Rekrutierung geschlossen! Helmut Salih, Clofarabine bei Patienten mit rezidivierter ode refraktärer akuter myeloischer Leukämie Bridge-Studie Clofarabine salvage therapy in patients with relapsed or refractory The BRIDGE Trial Johannes Schetelig, Dresden Wolfgang Bethge, Registry Study on Patient Characteristics, Biological Disease Profile and Clinical Outcome in Acute Myeloid Leukemia and Related Neoplasms, and Higher Risk Myelodysplastic Syndrome. The Biology and Outcome (BiO)-Project. Helmut Salih, Phase III Studie zu Chemotherapie in Kombination mit All-Trans Retinsäure (ATRA) mit oder ohne Gemtuzumab Ozogamicin bei Patienten mit Akuter Myeloischer Leukämie () und Mutation im Nucleophosmin 1 (NPM1) Gen (SG 09-09). Studie zur Rekrutierung geschlossen! Helmut Salih,

2 Randomized phase III study of intensive chemotherapy with or without da-satinib (Sprycel ) in adult patients with newly diagnosed core-binding factor acute myeloid leukemia (CBF-). (SG 21-13). Phase Ib/IIa study of palbociclib in MLLrearranged acute leukemias. (SG 23-14). 10-day decitabine versus conventional chemotherapy ( 3+7 ) followed by allografting in patients 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group [-21]. (EORTC 1301-LG). Michael Lübbert, Freiburg A PHASE 3, MULTICENTER, OPEN LABEL, RANDOMIZED STUDY COMPARING THE EFFICACY AND SAFETY OF AG-221 (CC-90007) VERSUS CONVENTIONAL CARE REGIMENS IN OLDER SUBJECTS WITH LATE STAGE ACUTE MYELOID LEUKEMIA HARBORING AN ISOCITRATE DEHYDROGENASE 2 MUTATION. (AG ).

3 NAPOLEON-Register der deutschen Intergroup. (Napoleon). Phase I/II-Studie: Blasten-Sensibilisierung gegenüber dem Vitamin-Aderivat All- Trans-Retinsäure (ATRA) durch Tranylcypromin (TCP), einen Hemmstoff des Enzyms LSD1 (Lysin-Spezifische Demethylase 1), bei der Behandlung akuter myeloischer Leukämie () / MDS. (TRANSATRA). Michael Lübbert, Freiburg A Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 versus Salvage Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia ()with FLT3 Mutation. (Astellas 2215-CL-0301). Andreas Neubauer, Marburg A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk acute promyelocytic leukemia - APOLLO-TRIAL. Uwe Platzbecker, Dresden

4 A Phase 2/3 Multicenter, Open-label, 3- arm, 2-stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia with FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy Carsten Müller-Tidow, Halle (Saale) A Phase 3, Double-Blind, Placebo- Controlled Study Of Quizartinib (AC220) Administered In Combination With Induction And Consolidation Chemotherapy, And Administered As Maintenance Therapy In Subjects 18 to 75 Years Old With Newly Diagnosed FLT3 ITD (+) Acute Myeloid Leukemia. (QUANTUM-First) Krämer, Heidelberg Helmut Salih, Randomized Phase II trial with safety runin phase evaluating low-dose azacitidine, ATRA and pioglitazone versus standard dose azacitidine in patients >=60 Jahre with who are refractory to standard induction chemotherapy. SG / -VIVA Simone Thomas, Regensburg Helmut Salih, First in man study to evbaluate the safety, tolerability amd preliminary efficacy of tzhe Fc-optimized FLT3 antibody FLYSYN for the treatment of acute myeloid leukemia patients with minimal residual disease FLYSYN-Studie. Helmut Salih,

5 Dose-Finding Run-in Phase I Followed by a Phase III, Multiceter, Randomized, Double-Blind, Placebo-controlled Study of Crenolanib in Combination with Chemotherapy in Patients with Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations. (SG / ARO-007) Marcus Schittenhelm,