Medizinische Klinik A

AML-Primärtherapie

DaunoDouble Studie  
Randomized Comparison between two dose levels of Daunorubicin and between one versus two Cycles of Induction therapy of adult Patients ≤60 with AML; Eudra CT  2013-003191-12

BLAST Studie  
A double-blind, placebo controlled, randomized, multicenter, Phase II Study to assess the efficacy of BL-8040 Addition to Consolidation Therapy in AML patients  (< 75 Jahre); EudraCT  2014-002702-21

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; EudraCT 2016-004907-30

AML-Rezidivtherapie / Refraktärtherapie 

PhiBi (F16IL2CD33) Studie
A Phase I study of the tumor-targeting human F16IL2 monoclonal antibody-cytokine fusion protein in combination with the anti-CD33 antibody BI 836858 in patients with AML relapse after allogeneic hematopoietic stem cell; EudraCT 2015-004763-37

TUD-PEMAZA-068
MRD-guided treatment with pembrolizumab and azacitidine in NPM1mut AML patients with an imminent hematological relapse – PEMAZA Trial; EudraCT 2017-004110-25

FT-2102-HEM-101(Forma) 
A Phase 1/2, Multicenter, Open-label Study of FT-2102 as a Single Agent and in Combination with Azacitidine or Cytarabine in Patients with Acute Myeloid Leukemia or Myelodysplastic Syndrome with an IDH1 Mutation; EudraCT 2017-001051-32

TEAM-Trial
Targeting Epigentic therapy resistance in AML with Bortezomib: A multi-center matched threshold crossing phase II approach; EudraCT 2017-005158-12

ARO-013
Phase III randomized, double-blind, placebo-controlled study investigating the efficacy of the addition of Crenolanib to Salvage Chemotherapy versus SAlvage Chemotherapy alone in subjects ≤ 75 years of age with relapsed/refractory FLT3 mutated AML; EudraCT 2017-001600-29

Nilo-Deep-R Studie
A PhaseIV single arm, multicenter, open-label study assessing deep molecular response in adult patients with newly diagnosed Philadelphia chromosome   positiv CML in chronic phase after two years of treatment with neilotinib 300mg BID; EudraCT 2015‐000968‐34

DasaHIT Studie
(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); EudraCT 2015-003502-16

ENDURE-CML Studie 
ENDURE Efficacy and Safety of Pegylated-Proline-Interferon Alpha 2B (AOP2014) in Maintaining Deep Molecular Remissions in Patients with Chronic Myeloid Leukemia (CML) who discontinue Phase II, Multicenter Trial with Post-Study Follow-up; Eudra-CT   2016-001030-94

polycythemia vera (PV) or essential thrombocythemia (ET) Ruxo-BEAT Studie
PV vs. ET, Ruxolitinib vs. best available therapy (Imonotherapy with i.e. Hydroxyurea, anagrelide, PEG-interferon, Busulfan, ...); EudraCT 2016-001030-94

Gastrointestinale Tumoren

RAMTAS
A Phase IIb study with run in safety phase of RAMucirumab in combination with TAS102 vs. TAS102 monotherapy in chemotherapy refractory metastatic colorectal cancer patients; EudraCT 2017-004162-99

ESOPEC
Vergleich der perioperativen Chemo-therapie (FLOT) mit der neoadjuvanten Radio-chemotherapie (CROSS) beim nicht metastasierten Adenokarzinom des Ösophagus (randomisierte Phase III); EudraCT 2015-001683-20

Hodgkin Lymphom - Primärtherapie

HD21-Studie                                     
Ein randomisiert-kontrollierter Vergleich von 6 Zyklen BEACOPP eskaliert und 6 Zyklen BrECADD beim fortgeschrittenen Hodgkin Lymphom“ (Phase III, multizentrisch, randomisiert); EudraCT 2014-005130-55

Hodgkin Lymphom - Rezidivtherapie

BV-Allo-Studie
Consolidation Therapy with Brentuximab Vedotin after Allogeneic Stem Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma - A multicenter phase II trial (in Zusammenarbeit mit dem KMT-Zentrum des UKM); EudraCT 2018-000873-59

DLBCL - Primärtherapie

R-CHOEP–brut Studie   
Ibrutinib and Standard Immuno-Chemotherapy (R-CHOEP-14) In Younger, High-Risk Patients with Diffuse Large B-Cell Lymphoma; Eudra CT  2017-003256-22 

OPTIMAL>60 Studie            
Improvement of Outcome and Reduction of Toxicity in Elderly Patients with CD20+ Aggressive B-Cell Lymphoma by an Optimised Schedule of the monoclonal Antibody Rituximab, Substitution of Conventional by Liposomal Vincristine, and FDG-PET based Reduction of Therapy in Combination with Vitamin D Substitution;  EudraCT 2010-019587-36

DLBCL - Rezidivtherapie

NIVEAU Studie                          
Improvement of Outcome in Elderly Patients or Patients not eligible for high-dose chemotherapy in first Relapse or Progression by adding Nivolumab to Gemcitabine, Oxalipatin plus Rituximab in case of CD20+ Disease; EudraCT 2016-002272-27

MOR208204, , Morphosys-Studie/B-MInd
A Phase II/III, Randomised, Multicentre Study of MOR00208 with Bendamustine versus Rituximab with Bendamustine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT) – B-MIND; EudraCT 2014-004689-11

ZNS-Lymphom - Primärtherapie

MARTA Studie                                
Age-adjusted high-dose chemotherapy and autologous stem cell transplant in elderly and fit primary CNS lymphoma patients; EudraCT 2016-001628-72

Mantelzelllymphom - Primärtherapie

TRIANGLE Studie                      
Autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing induction in generalized matle cell Lymphoma – a European mcl network study; EudraCT 2014-001363-12

Mantelzelllymphom - Rezidivtherapie

Follikuläres Lymphom - Rezidivtherapie

GAZAI
Therapy of NODAL Follicular Non Hodgkin Lymphoma (WHO grade ½) in Clinical Stage I/II using Response Adapted Involved Site Radiotherapy in Combination with Gazyvaro; EudraCT 2016-002059-89

PTLD2
Risk-Stratified sequential Treatment of Post-Transplant Lymphoproliferative Disease with 4 courses of Rituximab SC Followed by 4 couses of RituximabSC, 4 Courses of Rituximab SC combinated with CHOP-21 or 6 courses of Rituximab SC combinated with Alternating CHOP-21 and DHAOX: the PTLD-2 Trail; EudraCT 2013-004479-11

GO29781
An open-label, multicenter, phase i/ib trial evaluating the safety and pharmacokinetics of escalating doses of btct4465a as a single agent and combined with atezolizumab in patients with relapsed or refractory b-cell non-hodgkin’s lymphoma and chronic lymphocytic leukemia; EudraCT 2017-003267-35

Lymphomplasmozytisches Lymphom/ Waldenström - Rezidivtherapie

First-Line –Studien:

GMMG - HD 7
A randomized phase III trial assessing the benefit of the addition of isatuximab to lenalidomide / bortezomib / dexamethasone (RVd) induction and lenalidomide maintenance in patients with newly diagnosed multiple myeloma (GMMG HD7-Studie); Eudra-CT-Nr. 2017-004768-37

DSMMXVII
Elotuzumab (E) in Combination with Carfilzomib, Lenalidomide and Dexamethasone (E-KRd) versus KRd prior to and following Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma and Subsequent Maintenance with Elotuzumab and Lenalidomide versus Single-Agent Lenalidomide.A phase III study by DSMM (Deutsche Studiengruppe Multiples Myelom); EudraCT 2017-001616-11

Rezidiv-Studien:

DSMMXV
Pomalidomid, Ixazomib, und Dexamethason (PId) mit oder ohne Intensivierung durch Cyclophosphamid (PICd): Phase II Studie bei refraktärem oder rezidivierendem Multiplen Myelom (DSMM XV); EudraCT-Nr. 2014-001757-16

I. INCB 01158-206 
A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma
 
II. Amgen: Carfilzomid, Pomalidomid und Dexamethason
An Open-label, Phase 2 Study Treating Subjects
with First or Second Relapse of Multiple
Myeloma with Carfilzomib, Pomalidomide, and
Dexamethasone (KPd)​

BI 1199.214 (SENSIC) Studie
A double blind, randomized, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with ‘Systemic Sclerosis associated interstitial lung disease‘ (SSc-ILD); EudraCT 2015-000392-28

FASST Studie
A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis. (FASST); EudraCT 2015-001617-27

BIOLUMA Studie
A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in relapsed lung cancer and to evaluate biomarkers predictive for response to immune checkpoint inhibition; EudraCT 2016-003334-25

ATLAS Studie
Characterization of the sensitization spectrum towards frequent and rare inhalation allergens in patients with severe asthma with special emphasis on regional differences;

ABBVIE Studie
Open-Label, Single Arm, Phase 3b Study Evaluating the Safety of Rovalpituzumab Tesirine for Third-Line and Later Treatment of Subjects with Relapsed or Refractory DLL3 Expressing Small Cell Lung Cancer; EudraCT 2017-003173-33

Auskultationsstudie
Digital Auscultation Test - Development of an Innovative Approach - using modern technologies - to improve the diagnosis of rare lung diseases – expanded data collection Idiopathic Pulmonary Fibrosis; 1199.225 SENSCISTM- ON (Extension) Studie
An open-label extension trial to assess the long term safety of nintedanib in patients with ‘Systemic Sclerosis associated Interstitial Lung Disease’ (SSc-ILD); EudraCT 2016-003403-66

Sarkome Primärtherapie

Fibrosarc (PH-L19TNFDOX2) Studie    
A phase III study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with advanced or metastatic soft tissue sarcoma; EudraCT  2016-003239-38

Sarkome Rezidivtherapie

NiTraSarc Studie
Combined treatment with Nivolumab and Trabectedin in patients with metastatic or inoperable soft tissue Sarcomas - The NiTraSarc Phase II Trial; EudraCT 2017-001083-38

FLASH
A randomized study to investigate the efficacy and sefety of the tumor-targeting human antibody-cytokine fusion protein L19TNF in previously treated patients with advanced stage or metastatic soft-tissue sarcoma; PH-L19TNFSARC-03/18; EudraCT 2018-004104-19

CUPISCO
A phse II, randomized, active-controlled, multi-center study comparing the efficacy and safety of targeted therapy or cancer Immunotherapy guided by genomic profiling versus platinum-based chemotherapy in patients with cancer of unknown primary site who have received three cycles of platinum doublet chemotherapy; EurdaCT 2017-003040-20

Thorax-Onkologische Tumore

BIOLUMA Studie
A phase II trial of nivolumab in combination with ipilimumab to evaluate efficacy and safety in relapsed lung cancer and to evaluate biomarkers predictive for response to immune checkpoint inhibition; EudraCT 2016-003334-25