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
 
AbbVie Studie  
A Randomized, Double-Blind, Placebo Controlled Study of Venetoclax in Combination with Azacitidine Versus Azacitidine in Treatment Naive Elderly Subjects with Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy; EudraCT  2016-001466-28

BIBF1120  in AML  Studie        
Randomised, multi-center, placebo-controlled, Phase I/II study of Nintedanib in combination with LDAC in elderly patients with AML unfit for intensive chemotherapy; EudraCT 2011-001086-41
 
Quantum-first Studie
A Phase 3, Double.Blind, Placebo-Controlled Study of quizartinib (AC220) administered in combination with Induction and Consolidation Chemotherapy, and administered as Maintenace therapy in subjects 18 to 75 years old with newly diagnosed FLT3-ITD (+) acute myeloid leukemia; EudraCT 2015-004856-24

BI1315.2 Studie              
Open-Label, Phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine for patients with acute myeloid leukemia; Eudra-CT  2015-002892-30

AML-Rezidivtherapie / Refraktärtherapie

BI1315.2 Studie            
Open-Label, Phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine for patients with acute myeloid leukemia; Eudra-CT  2015-002892-30

BIBF1120  in AML Studie         
Randomised, multi-center, placebo-controlled, Phase I/II study of Nintedanib in combination with LDAC in elderly patients with AML unfit for intensive chemotherapy; EudraCT 2011-001086-41

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

APOLLO Studie
APL; A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracyclines-based chemotherapy (AIDA regimen) for patients with newly diagnosed, high-risk APL;  EudraCT 2015-001151-68

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

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

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

MATRIX/IELSG43 Studie       
High-dose chemotherapy and autologous stem cell transplant or consolidating conventional chemotherapy in primary CNS lymphoma-randomized phase III Trial; EudraCT  2012-000620-17

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

ACE-LY-308 Studie                    
A Phase 3, Randomized, Double blind, Placebo controlled, Multicenter Study of BR alone Versus in Combination with Acalabrutinib (ACP 196) in Subjects with Previously Untreated Mantle Cell Lymphoma; EudraCT 2015-005220-26

MCL R2 elderly Studie                     
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; EudraCT 2012-002542-20

Mantelzelllymphom - Rezidivtherapie

MO39107 Studie                                   
A Phase II study exploring the safety and efficacy of Atezolizumab administered in combination with Obnituzumab or Rituximab in patients with relapsed/refractory Mantle Cell Lymphoma, Marginal Zone Lymphoma and Waldenström Macroglobulinemia ; EudraCT 2016-003579-22

Follikuläres Lymphom - Rezidivtherapie

CHRONOS-4 Studie                        
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); EudraCT 2015-001088-38

Lymphomplasmozytisches Lymphom/ Waldenström - Rezidivtherapie

MO39107 Studie                                   
A Phase II study exploring the safety and efficacy of Atezolizumab administered in combination with Obnituzumab or Rituximab in patients with relapsed/refractory Mantle Cell Lymphoma, Marginal Zone Lymphoma and Waldenström Macroglobulinemia ; EudraCT 2016-003579-22 

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

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

BIRMA
LGX818 in combination with MEK162 in refractory or relapsed multiple myeloma patients with BRAFV600E or BRAFV600K mutation; Eudra-CT-Nr. 2014-004597-42

GMMG-Dante
DAratumumab iN combination with BorTEzomib and Dexamethasone in subjects with relapsed or relapse and refractory Multiple Myeloma and severe renal impairment including subjects undergoing hemodialysis. A phase 2, open-label, multicenter trial; Eudra-CT-Nr. 2016-000433-51

SMM:

Aquila
A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects with High-risk Smoldering Multiple Myeloma; Eudra-CT-Nr. 2016-001205-16

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

tTF-NGR Studie                                         
Phase I Study of tTF-NGR in Patients with recurrent or refractory malignant tumors and lymphomas beyond all standard Treatments; EudraCT 2016-003042-85

PH-L19TNFDOXO-01/12 Studie
Phase Ib study of the tumor-targeting human L19TNFα monoclonal antibody-cytokine fusion protein in combination with doxorubicin in patients with advanced solid tumors; EudrCT 2012-000950-75