ÜBERSICHT zu KLINISCHEN STUDIEN der Abteilung für HÄMATOLOGIE / ONKOLOGIE / HÄMOSTASEOLOGIE

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1 ÜBERSICHT zu KLINISCHEN STUDIEN der Abteilung für HÄMATOLOGIE / ONKOLOGIE / HÄMOSTASEOLOGIE Liebe Kolleginnen und Kollegen, diese Studienübersicht soll Ihnen einen Überblick zu allen aktiven und geplanten hämatologisch sowie onkologischen Therapiestudien am geben. Unser Ziel ist es Patienten die bestmögliche Versorgung nach aktuellem Stand der klinischen Forschung anzubieten. Sie finden die Studien nach Indikationen sortiert. Bitte nehmen Sie mit der Studienassistenz oder mit dem angegebenen Prüfern Kontakt auf, wenn Sie weitere Informationen zu einer Studie erhalten wollen. Wir freuen uns auf eine intensive Kooperation mit Ihnen und hoffen im Sinne der Patienten. Mit kollegialen Grüßen Inhalt Myeloische Erkrankungen Lymphatische Erkrankungen Transplantationsstudien Solide Tumore Register und NIS Ansprechpartner Karolin Hubert Krukenberg-Krebszentrum Halle Koordination zentrales Studienmanagement Ernst-Grube-Straße Halle/Saale Telefon: Fax: karolin.hubert@uk-halle.de Stand vom von 9

2 Myeloische Erkrankungen Akute Myeloische Leukämie (AML) Primärtherapie 2215-CL-0201 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 TUD-2DAUNO-058/ DaunoDouble Randomized comparison between two dose levels of daunorubicin and between one versus two cycles of induction therapy for adult patients with acute myeloid leukemia 65 years AC220-A-U302/ QUANTUM FIRST CLINICAL STUDY PROTOCOL A PHASE 3, DOUBLE-BLIND, PLACEBOCONTROLLED 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 TUD-Delta1-063 A randomized placebo-controlled phase 2 study of decitabine with or without eltrombopag in AML patients 65 years of age not eligible for intensive chemotherapy BLAST Doppelblinde, Placebo-kontrollierte, randomisierte, multizentrische Phase II Studie zur Beurteilung der Wirksamkeit von BL-8040 in der Konsolidierungstherapie bei AML EORTC 1301 LG 10-day decitabine versus conventional chemotherapy ( 3+7 ) followed by allografting in AML patients 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group. BIBF 1120 Eine randomisierte, Placebo-kontrollierte, multizentrische Studie zur Erfassung der Effektivität von Nintedanib (BIBF 1120) in Kombination mit niedrig-dosiertem Cytarabin bei älteren Patienten mit nicht intensiv behandelbarer AML FT-2102-HEM-101 Karolin Hubert A Phase 1/2, Multicenter, Open-label, Study of FT-2102 as a Single Agent and in Combination with Azacitidine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 R132 Mutation Stand vom von 9

3 PEMAZA MRD-guided treatment with pembrolizumab and azacitidine in NPM1mut AML patients with an imminent hematological relapse PEMAZA Trial Myelodysplastische Syndrome (MDS) Primärtherapie EUROPE PROSPECTIVE VALIDATION OF A PREDICTIVE MODEL OF RESPONSE TO ROMIPLOSTIM IN PATIENTS WITH IPSS LOW OR INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROME (MDS) AND THROMBOCYTOPENIA M A Randomized Phase 2 Study Evaluating the Safety, Pharmacokinetics and Efficacy of Venetoclax in Combination with Azacitidine Compared with Azacitidine Alone in Subjects with Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS) Zweitlinien-Therapie SGI / ASTRAL-3 A Phase 3, Multicenter, Randomized, Open-Label Study of Guadecitabine (SGI-110) versus Treatment Choice in Adults with Myelodysplastic Syndromes (MDS) or Chronic Myelomonocytic Leukemia (CMML) Previously Treated with Hypomethylating Agents Myeloproliferative Erkrankungen (MPN) Primärtherapie INCB A Phase 2, Open-Label, Monotherapy, Multicenter Study to Evaluate the Efficacy and Safety of INCB in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement CTC12729/ MMM 02 Study Ruxolitinib versus allogeneic stem cell transplantation for patients with myelofibrosis according to donor availability: A prospective phase II trial Ruxo-BEAT Ruxolitinib versus Best Available Therapy in patients with high-risk polycythemia vera or high-risk essential thrombocythemia INCB An Open-Label Phase 2 Study of Itacitinib (INCB039110) in Combination With Low Dose Ruxolitinib or Itacitinib Alone Following Ruxolitinib in Subjects With Myelofibrosis Stand vom von 9

4 Zweitlinientherapie KRT An Open-Label, Phase 2a/2b Study of KRT-232 in Subjects With Primary Myelofibrosis (PMF), Post Polycythemia Vera MF (post PV-MF), Or Post Essential Thrombocythemia MF (post ET-MF) Who Have Failed Ruxolitinib KRT A Two-Part, Randomized, Open-label, Multicenter, Phase 2a/2b Study of the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KRT-232 Compared to Ruxolitinib in Patients with Phlebotomy-Dependent Polycythemia Vera Chronisch Myeloische Leukämie (CML) DasaHIT DasaHIT trial (Dasatinib Holiday for Improved Tolerability) Treatment optimization for patients with chronic myeloid leukemia (CML) with treatment naïve disease (1st line) and patients with resistance or intolerance against alternative Abl-Kinase Inhibitors ( 2nd line). CAMN107ADE20/ Nilo Deep R A Phase IV single arm, multicenter, open-label study assessing deep molecular response in adult patients with newly diagnosed Philadelphia chromosome positive CML in chronic phase after two years of treatment with nilotinib 300mg BID CAMN107ADE22T/ NAUT Antje Kleinbauer Einschätzung der Wirksamkeit von Nilotinib nach einem ersten erfolglosen Aussetzen der Therapie sowie die Beständigkeit der molekularen Remission nach dem zweiten TKI-Absetzen bei chronischer myeloischer Leukämie im Rahmen einer multizentrischen, prospektiven Studie Zweitlinien-Therapie MED / BODO Multicenter, open-label single arm phase II study testing the tolerability and the efficacy of Bosutinib step-in dosing in Chronic Phase CML patients intolerant or refractory to previous Nilotinib or Dasatinib therapy Chronisch Myelomonozytäre Leukämie (CMML) DACOTA A Randomized Phase III study of Decitabine with or without Hydroxyurea versus Hydroxyurea in patients with advanced proliferative Chronic Myelomonocytic Leukemia SGI / ASTRAL-3 siehe Myelodysplastische Syndrome Stand vom von 9

5 Paroxysmale nächtliche Hämoglobinurie (PNH) PROSPECT Retro- and prospective study to evaluate the prevalence of paroxysmal nocturnal hemoglobinuria (PNH) in patients with splanchnic vein thromboses (SVT) Lymphatische Erkrankungen INCB siehe Myeloproliferative Erkrankungen Akute Lymphatische Leukämie (ALL) GMALL Principal Investigator: Dr. med. Sandra Paul Phase IV-Studie mit einem Phase III-Teil zur Evaluation der Sicherheit und Wirksamkeit von Nelarabin bei T-ALL EWALL-BOLD Principal Investigator: Kinga Ligeti Phase II trial for the treatment of older patients with newly diagnosed CD19 positive, Ph/BCR-ABL negative B- percursor acute lymphoblastic leukemia with sequential dose reduced chemotherapy and Blinatumumab (EWALL- BOLD) Non-Hodgkin Lymphome (NHL) Primärtherapie IELSG43 MATRix High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma randomized phase III trial GABe 2016 FIRST LINE THERAPY OF ADVANCED STAGE FOLLICULAR LYMPHOMA IN PATIENTS NOT ELIGIBLE FOR STANDARD IMMUNOCHEMOTHERAPY Prospective randomized comparison of single agent GA101 versus GA101 plus Bendamustine followed by GA101 in medically non-fit patients BAY /17067 CHRONOS 3 A Phase III, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of copanlisib in combination with rituximab in patients with relapsed indolent B-cell non-hodgkin s lymphoma (inhl) BAY /17833 CHRONOS 4 A Phase III, randomized, double-blind, controlled, multicenter study of intravenous PI3K inhibitor copanlisib in combination with standard immunochemotherapy versus standard immunochemotherapy in patients with relapsed indolent non-hodgkin s lymphoma (inhl) Stand vom von 9

6 BGB-A A Phase 2, Open-Label Study of BGB-A317 in Patients with Relapsed or Refractory Mature T- and NK-cell Neoplasms Multiple Myelome (MM) CLBH589D2222/ Principal Investigator: Dr. med. Judith Schaffrath Panorama-3 A multicenter, randomized, open-label Phase 2 study evaluating the safety and efficacy of three different regimens of oral panobinostat in combination with subcutaneous bortezomib and oral dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma who have been previously exposed to immunomodulatory agents Transplantationsstudien DKMS-1601/ HAMLET A randomized controlled study comparing outcome after hematopoietic cell transplantation from a partially matched unrelated versus haplo-identical donor (HAMLET) Akute Myeloische Leukämie (AML) Zweitlinien-Therapie 2215-CL-0304 Non-Hodgkin Lymphome (NHL) A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Trial of the FLT3 Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients with FLT3/ITD AML ETAL-3-ASAP Evaluation of the impact of remission induction chemotherapy prior to allogeneic stem cell transplantation in relapsed and poor-response patients with AML / CHARLY PHASE-II STUDY ON THE VALUE OF POST-TRANSPLANT CYCLOPHOSPHAMIDE AFTER THIOTEPA-BASED HAPLOIDENTICAL STEM CELL TRANSPLANTATION FOR RELAPSED/REFRACTORY NON-HODGKIN LYMPHOMA DSHNHL R7 ASTRAL An open, randomized Phase III clinical study to compare standard versus predefined use of plerixafor for mobilization of autologous peripheral blood stem cells and to compare autologous with allogeneic stem cell transplantation as treatment of primary progressive and relapsed aggressive Non-Hodgkin Lymphoma via risk adapted stratification Allogeneic Stem Cell Transplantation in Relapsed Aggressive Non-Hodgkin Lymphoma Stand vom von 9

7 Cytomegalievirus (CMV) SHP / AURORA A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients Solide Tumore Gastrointestinale Stromatumore (GIST) AIO-YMO-0111/ MATEO Principal Investigator: Dr. med. Jörn Rüssel Antje Kleinbauer Randomized controlled trial of S-1 maintenance therapy in metastic esophagogastric cancer Kopf- und Halstumore HANNA Principal Investigator: Dr. med. Jörn Rüssel Antje Kleinbauer A national, prospective, non-interventional study (NIC) of Nivolumab (BMS ) in patients with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy Register, nicht interventionelle Studien, Forschungsprojekte SAL-AML Register Christina Zahn AML-Register und Biomaterialdatenbank der Studienallianz Leukämie (SAL) NAPOLEON National acute promyelocytic leukemia (APL) observational study NAPOLEON Register der Deutschen AML Intergroup GSG-MPN Register SAL-MPN-Register und Biomaterialdatenbank der Studienalianz Leukämie (SAL) GMALL-Register und Biomaterialbank Dr. med. Nadja Jäkel Biomaterialsammlung und prospektive Datenerfassung zu Diagnostik, Behandlung und Krankheitsverlauf der ALL des Erwachsenen HRYD-033 Diagnostic project to determine the prevalence of mastocytosis in patients with cytopenia or leucocytosis Stand vom von 9

8 HINC-207 Pheno- and genotypes of JAK2 mutated patients with and without thrombotic events. A project of the East German Study Group (OSHO) Ponderosa Beobachtungsstudie mit Patienten mit CML in allen Phasen, die mit Ponatinib behandelt werden (Iclusig ) in jeglicher Dosierung behandelt werden Mzol 2015 Dr. med. Thomas Weber Nichtinterventionelles prospektives Register zu Epidemiologie und Behandlungspraxis bei Marginalzonenlymphomen Varianz Principal Investigator: Dr. med. Jörn Rüssel Antje Kleinbauer Vorhersage von Ansprechen oder Resistenz durch Identifizierung von Biomarkern beim Adenokarzinom des Magens und des gastroösophagealen Übergangs innerhalb einer nicht-interventionellen Studie und zielgerichteter Therapie mit Trastuzumab YonSar Nichtinterventionelle Studie zur Wirksamkeit und Sicherheit von Trabectedin (Yondelis ) bei Patienten mit fortgeschrittenem Weichteilsarkom Stand vom von 9

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