Für Patienten mit fortgeschrittenen Tumorerkrankungen aber auch für Patienten mit neu diagnostizierten Erkrankungen stellen klinische Studien mit neuen therapeutischen Weiterentwicklungen und innovativen Therapieansätzen eine wichtige Option und Hoffnung dar.
Die Medizinische Klinik II führt daher zahlreiche Therapiestudien für verschiedene Tumorerkrankungen durch und ist an vielen multizentrischen Studien beteiligt. Durch die Teilnahme an klinischen Studien bestehen für Patienten neue therapeutische Möglichkeiten, da sich viele bislang nicht zugelassene Medikamente in der Erprobung befinden und in klinischen Studien hinsichtlich ihrer Wirksamkeit und Verträglichkeit geprüft werden.
Verschaffen Sie sich einen ersten Überblick über aktuelle Studien am UKSH in unserem QuickQueck-Portal.
In unserer aktuellen Studienübersicht haben wir für Sie ausführliche Informationen über alle aktuell laufenden Therapie-Studien der Medizinischen Klinik II zusammengestellt:
akute Leukämien
Ansprechpartner
Dr. med. Lars Fransecky
Facharzt für Innere Medizin und Hämatologie/Onkologie, Stationsoberarzt Hämatologische Spezialstation
Tel. Kiel: 0431 500-22555Fax: 22554
Studien
| EudratCT | Phase | Studientitel | Entität | |
| 2018-001588-22 | Phase 3 | Rafael Armada 2000 | Phase III multicenter open label randomized trial to evaluate Efficacy and Safety of CPI-613 in Combination with High Dose Cytarabine and Mitoxantrone ( CHAM ) Compared to High Dose Cytarabine and Mitoxantrone (HAM) in older Patients (> 60 Years) with relapsed/ refractory Acute Myeloid Leukemia (AML) | AML |
| 2019-003863-23 | Phase I and II | Mosaic | MidOStaurin + Gemtuzumab OzogAmIcin Combination in Firstline Standard Therapy for Acute Myeloid Leukemia | AML |
| 2019-003913-32 | Phase III | GNG | Randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare intensive postremission therapy double blinded with or without glasdegib in older patients with newly diagnosed AML | AML |
| 2016-004907-30 | Phase III | Agile | A Phase 3, Multicenter, Double-Blind,Randomized,Placebo-Controlled Study of AG-120 in Combination with Azacitidine in Subjects > 18 Years of Age with Previously Untreated Acute Myeloid Leukemia with an IDH1 Mutation | AML |
| 2015-001151-68 | Phase III | Apollo | A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regim) for patients with newly diagnosed, high-risk acute pro myelocytic leukemia | AML |
| 2013-003466-13 | Phase III | GMALL 08/2013 | Therapieoptimierung bei erwachsenen Patienten mit neu diagnostizierter akuter lymphatischer Leukämie (ALL) oder lymphoblastischem Lymphom (LBL) durch individualisierte, gezielte und intensivierte Therapie | ALL |
| 2015-000733-76 | Phase II | GMALL MOLACT1-BLINA | A multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lympho-blastic leukemia (Blast Successor Trial) | ALL |
| Phase II | EWALL-Bold | Phase II trial for the treatment of older patients with newly diagnosed CD19 positive, Ph/BCR-ABL negative B-precursor acute lymphoblastic leukemia with sequential dose reduced chemotherapy and Blinatumomab | folgt | |
| 2013-003117-18 | Phase III | AMLSG 21-13 | Randomized Phase III Study of Intensive Chemo -therapy with or without Dasatinib (Sprycel) in Adult Patients with Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML) | AML |
chronische Leukamien
Ansprechpartner
Dr. med. Björn-Niklas Heydrich
Facharzt für Innere Medizin, Hämatologie/Onkologie und Palliativmedizin, Stationsoberarzt Hämatologisch-onkologische Station
Tel. Kiel: 0431 500-22555Fax: 22554
Studien
| EudratCT | Phase | Studientitel | Entität | |
| 2020-002142-17 | Phase II | A PROSPECTIVE, MULTICENTRE PHASE-II TRIAL OF ACALABRUTINIB IN VERY OLD (>80Y) OR FRAIL PATIENTS WITH CLL | CLL-Frail | |
| keine | Register | Registry of the German CLL Study Group: Long term follow-up of patients with CLL, B-PLL, T-PLL, SLL, T/ NK-LGL, HCL and Richter’s transformation | CLL | |
| 2019-003854-99 | Phase III | CLL-17 | A phase 3 multicenter, randomized, prospective, open-label trial of ibrutinib monotherapy versus fixed-duration venetoclax plus obinutuzumab versus fixed-duration ibrutinib plus venetoclax in patients with previously untreated chronic lymphocytic leukemia (CLL) | CLL |
| 2018-003270-27 | Phase II | CLL2 BZAG | TRIAL PROTOCOL A PROSPECTIVE, OPEN-LABEL, MULTICENTER PHASE-II-TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A SEQUENTIAL REGIMEN OF BENDAMUSTINE FOLLOWED BY OBINUTUZUMAB (GA101), ZANUBRUTINIB (BGB-3111) AND VENETOCLAX (ABT-199) IN PATIENTSWITH RELAPSED/REFRACTORY CLL | CLL |
| 2018-002492-17 | Phase II | CLL RT1 | A PROSPECTIVE, OPEN-LABEL, MULTICENTRE PHASE-II-TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ZANUBRUTINIB (BGB-3111), A BTK INHIBITOR, PLUS TISLELIZUMAB (BGB-A317), A PD-1 INHIBITOR, FOR TREATMENT OF PATIENTS WITH RICHTER TRANSFORMATION | CLL |
| 2016-002768-15 | Phase II | Umbrella 2 | A Prospective, Randomized, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of GS-4059 and Entospletinib with and without Obinutuzumab | CLL |
| 2015-004606-41 | Phase II | CLL2-GIVe | A prospective, open-label, multicentre phase-II trial of ibrutinib plus venetoclax plus obinutuzumab in physically fit (CIRS ≤ 6 & normal creatinine clearance) and unfit (CIRS > 6 & creatinine clearance ≥ 50 ml/min) patients with previously untreated chronic lymphocytic leukemia (CLL) with TP53 deletion (17p-) and/or mutation | CLL |
| 2014-000590-39 | Phase II | CLL Bio | A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by ibrutinib and ofatumumab (BIO) followed by ibrutinib and ofatumumab maintenance in CLL patients | CLL |
| 2012-005214-15 | Phase III | PATH | A prospective, randomized, open label two arm Phase III study to evaluate treatment free remission (TFR) rate in patients with Philadelphia-positive CML after two different durations of consolidation treatment with nilotinib 300mg BID | CML |
| 2010-024262-22 | Phase III | Treatment optimization of Ph/BCR-ABL positive patients with chronic myeloid leukemia (CML) in chronic phase with nilotinib induction and nilotinib or interferon alpha maintenance therapy | CML | |
| 2015‐003502‐16 | Phase III | DasaHIT | 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) | CML |
maligne Lymphome
Ansprechpartner
Prof. Dr. med. Christiane Pott
Stellvertretende Direktorin, Leiterin des Schwerpunktes Lymphome
Tel. Kiel: 0431 500-22502Fax: 22508
Dr. med. Dominique Wellnitz
Fachärztin für Innere Medizin, Hämatologie/Onkologie, Notfallmedizin und Palliativmedizin, Oberärztin, Leiterin der interdisziplinären Therapieambulanz, Leitung Zytomorphologie
Studien
| EudratCT | Phase | Studientitel | Entität | |
| 2020-003288-24 | Phase 3 | MYF3001 | A Randomized Open-Label, Phase 3 Study to Evaluate Imetelstat (GRN163L) Versus Best Available Therapy (BAT) in Patients with Intermediate-2 or High-risk Myelofibrosis (MF) Refractory to Janus Kinase (JAK)-Inhibitor | |
| 2018-002115-96 | Phase III | OptiMATe | Optimizing MATRix as remission induction in PCNSL: De-escalated induction treatment in newly diagnosed primary CNS lymphoma – a randomized phase III trial | |
| 2019-001268-31 | Phase Ib | Morphosys First-MIND | A Phase Ib, open-label, randomized study to assess safety and cell lymphoma MOR00208 plus Lenalidomide in addition to R-CHOP in patients with newly diagnosed Diffuse Large B-Cell Lymphoma First-MIND | DLBCL |
| 2018-001141-13 | Phase Ib-II | GO40516 | AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE Ib/II TRIAL EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA | B-NHL |
| 2019-002930-35 | Phase II | TIGER CART-T | Phase Trial II of TIsaGElecleucel (Kymriah)in elderly Patient with first relapsed or primary refractaory aggressive B-cell non Hodgkin Lymphoma | B-NHL |
| 2018-004038-13 | Phase II | Alternative-C | A prospective multicenter Phase 2 Study of the Chemotherapy-free Combination of the intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination with Obinutuzumab in Patients with Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden | Foll. Lymhom |
| 2014-005164-15 | Phase II | Alternative | A Prospective Multicenter Phase 2 Study of the Chemotherapy-free Combination of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib) in Combination with Obinutuzumab (GA 101) in Patients with Previously Untreated Follicular Lymphoma (FL) and a high Tumor Burden | Foll. Lymphom |
| 2017-001175-23 | Phase I | SAKK 35/15 | A phase I trial of obinutuzumab in combination with venetoclax in previously untreated follicular lymphoma patients | Foll. Lymphom |
| 2014-005130-55 | Phase III | HD-21 | Treatment optimization trial in the first-line treatment of advanced stage Hodgkin lymphoma; comparison of 6 cycles of escalated BEACOPP with 6 cycles of BrECADD | M. Hodgkin |
| 2012-000620-17 | Phase III | MATRix | Hochdosis-Chemotherapie und autologe Stammzelltransplantation oder konventionelle Chemotherapie als Konsolidierung bei primären ZNS-Lymphomen - randomisierte, kontrollierte, offene, multizentrische Phase III Studie mit 2 parallelen Armen | ZNS-Lymphom |
| Register | Register | PTLD -Register | Deutsches PTLD-Register PTLD 2006-2012 | PTLD |
| 2013-004479-11 | Phase II | PTLD-2 | "Risk-stratified sequential treatment of post-transplant lymphoproliferative diseases with 4 courses of rituximab SC followed by 4 courses of rituximab SC, 4 cources of rituximab SC combined with CHOP-21 or 4 courses of rituximab SC combined with alternating CHOP-21 and DHAOx: The PTLD-2 trial" | PTLD |
| 2014-001363-12 | Phase II | Olymp-1 | OBINUTUZUMAB in MARGINAL ZONE LYMPHOMA | MZL |
| 2012-002542-20 | Phase III | MCL R2 elderly | Efficacy of alternating immunochemotherapy consisting of R-CHOP + R-HAD versus R-CHOP alone followed by maintenance therapy consisting of additional lenalidomide with rituximab versus rituximab alone for older patients with mantle cell lymphoma | MCL |
| Phase II | GOAL II | A prospective, multicenter randomized phase II trial investigating Gemcitabine/Oxaliplatin/Rituximab with or without Mor208 for patients with relapsed/refractory aggressive lymphoma - GOALII | nk |
solide Tumore
Studien
| EudratCT | Phase | Studientitel | Entität | |
| 2017-001832-21 | Phase III | KEYNOTE-671 | A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants with Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) | Lungen-Ca |
| 2016-004758-13 | Phase II | IMSTAR-HN | Multicenter randomized controlled study of nivolumab alone or in combination with ipilimumab as immunotherapy vs standard follow-up in surgical resectable HNSCC after adjuvant therapy (Kurztitel: IMSTAR HN) | Head/Neck Ca |
Phase I-Einheit
Medikamente die sich in einer frühen Phase der Erprobung befinden, werden im Rahmen von Phase I Studien geprüft. Hier bestehen besondere Anforderungen an die Durchführung und Überwachung der Patienten. Auf der Hämatologischen Spezialstation stehen zwei Betten für die besonderen Anforderungen zur Durchführung früher klinischer Studien zur Verfügung.