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Weitere Studien

PNH-Register

Paroxysmal Noctural Hemoglobinuria (PNH) Registry


Hauptprüfer Dresden:
Studiensekretariat: Michaela Weier Tel: +49 351 4583192


Krebs und der Sinn des Lebens aus der Perspektive der Partner der Betroffenen

Krebs und der Sinn des Lebens aus der Perspektive der Partner der Betroffenen

Krebs und der Sinn des Lebens aus der Perspektive der Partner der Betroffenen


Hauptprüfer Dresden:


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 ≤60 years

Randomisierter Vergleich zwischen zwei Dosierungen von Daunorubicin und zwischen Einfach- und Doppel-Induktionstherapie bei erwachsenen Patienten mit Akuter Myeloischer Leukämie ≤ 60 Jahre


Hauptprüfer Dresden: PD Dr. med. Christoph Röllig


SAWHI V.A.C.

Behandlung subkutaner abdomineller WHS ohne Faszialedehiszenz nach chirurg. Eingriff mittels V.A.C. versus Standardwundtherapie

A decision of the Federal Joint Committee Germany states that negative pressure wound therapy is not accepted as a standard therapy with full reimbursement by the health insurance companies in Germany. This decision is based on the rapid report and the final report of the Institute for Quality and Efficiency in Health Care, which demonstrated through systematic reviews and meta-analysis of previous study projects that an insufficient state of evidence regarding the use of negative pressure wound therapy (NPWT) for treatment of acute and chronic wounds exists. The independent scientific “Institute for Research in Operative Medicine” (IFOM) as part of the University of Witten / Herdecke and the manufacturer Kinetic Concepts Incorporated (KCI) initiated a study to evaluate the efficacy and effectiveness of NPWT for the treatment of subcutaneous abdominal wound healing impairment after surgery compared with standard conventional wound therapy.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: +49 351 45818354


Exzellenz-Netzwerks für neuroendokrine Tumoren (NeoexNET)

Exzellenz-Netzwerks für neuroendokrine Tumoren (NeoexNET)

'Das Exzellenz-Netzwerk für neuroendokrine Tumoren möchte systematisch die Beschwerden, Symptome, Folgeerkrankungen sowie die Sterblichkeit dieser verschiedenen neuroendokrinen Tumoren untersuchen.


Hauptprüfer Dresden:


ETAL3-ASAP

Evaluation of the impact of remission induction chemotherapy prior to allogeneic stem cell transplantation in relapsed and poor-response patients with AML A phase-III study on the comparison of two treatment strategies for patients with high-risk acute myeloid leukemia by the Study Alliance Leukemia (SAL)


Hauptprüfer Dresden:
Studiensekretariat: Sandra König Tel: +49 351 4587572


INFORM

INdividualized Therapy FOr Relapsed Malignancies in Childhood

Obwohl bei bösartigen Erkrankungen im Kindes- und Jugendalter mit modernen Behandlungsprotokollen inzwischen Heilungsraten von ca. 75% erzielt werden, bleiben Rückfälle und Progressionen von Hochrisikoerkrankungen ein enormes klinisches Problem. Nur ein kleiner Anteil der Patienten (ca. 10%) kann bei einem Rückfall noch geheilt werden. Dieses Problem soll mit dem INFORM-Projekt „INdividualized Therapy FOr Relapsed Malignancies in Childhood“ erstmalig grundlegend angegangen werden. Das INFORM-Konsortium ist ein Zusammenschluss aus führenden Ärzten und Wissenschaftlern auf dem Gebiet der Genomforschung und kinderonkologischen Studiengruppen der Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH).


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Hauptprüfer Dresden:
Studiensekretariat: Babett Seliger Tel: None


Prima

Evaluierung von prompt-gamma-imaging zur Reichweitenverifikation für die Protonenbestrahlung von Tumorpatienten

Evaluierung einer Prompt-Gamma-Kamera (PGK) für die Messung der Protonenreichweite während einer Routinebestrahlung mit Protonen.


Hauptprüfer Dresden:
Studiensekretariat: Tel: +49/351 458 2238


CLIMB

Eine prospektive Datenbank für kolorektale Lebermetastasen mit einem integrierten Qualitätssicherungsprogramm


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Hauptprüfer Dresden:
Studiensekretariat: Tel: +49 351 45818354


EMR100036-002

An Open Label, Phase Ia/Ib Trial of the DNA-PK Inhibitor MSC2490484A in Combination with Radiotherapy in Patients with Advanced Solid Tumors

This is a combined Phase Ia/Ib, open label, dose escalation, and dose expansion trial designed to explore the safety, tolerability, PK and PD profile, and clinical activity of MSC2490484A in combination with RT, and to determine the MTD and a RP2D for MSC2490484A in combination with RT. An ancillary cPoP study will be conducted in parallel with the Phase Ia/Ib core trial to explore the PD effect of MSC2490484A in combination with RT on target engagement in tumor tissue.


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Hauptprüfer Dresden: Prof. Dr. med. Michael Baumann
Studiensekretariat: Tel: +49/351 458 2238


Cassini

Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism.

The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.


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Hauptprüfer Dresden:
Studiensekretariat: Antje Reitter Tel: +49 351 458 3376


Hokusai DU176b-D-U311

A PHASE 3B, PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLIND EVALUATOR (PROBE) STUDY EVALUATING THE EFFICACY AND SAFETY OF (LMW) HEPARIN/EDOXABAN VERSUS DALTEPARIN IN VENOUS THROMBOEMBOLISM ASSOCIATED WITH CANCER.

This is a multinational, prospective, randomized, open-label, blind-evaluator (PROBE), non-inferiority study comparing edoxaban with dalteparin for prevention of the combined outcome of recurrent VTE or major bleeding in patients with VTE associated with cancer. One thousand subjects (1000) will be equally randomized to 1 of the 2 treatment groups. After a subject’s eligibility is confirmed, the subject will be stratified by 1) bleeding risk, and 2) the need for dose adjustment, and then randomly assigned via interactive voice/web response system (IXRS) in a 1:1 ratio to treatment with either LMWH/edoxaban or dalteparin (see details in Section 3.1.2.LMWH/Edoxaban group: Therapeutic doses of LMWH (subcutaneous [SC]) will be administered for at least 5 days; this 5 day period may include the pre-randomization LMWH (if applicable). The choice of this parenteral LMWH is up to the treating physician. Thereafter, edoxaban will be started orally at 60 mg once daily [QD] (2 × 30 mg tablets) (30 mg QD for subjects requiring dose adjustment) for the remainder of the treatment period. Dalteparin group: After randomization, dalteparin will be administered at a dose of 200 IU/kg SC (maximum daily dose 18,000 IU) for 30 days. The 30 day period may include the pre-randomization anticoagulant treatment if dalteparin was used in therapeutic doses. Thereafter (approximately Day 31 forward), dalteparin will be administered at a dose of 150 IU/kg SC (~ 75% - 83% of the initial dose) for the remainder of the treatment period. The intended treatment duration and follow-up for all subjects is 12 months, except for the final subject(s) randomized to the study. Once 1000 subjects are randomized, a global End-of-Treatment (EOT) date will be established that ensures a minimum of 6 months of study treatment and follow-up for the final subject(s) randomized. All subjects will permanently discontinue study treatment on or before the EOT date. After randomization subjects will be assessed at Month 1, Month 3, and quarterly thereafter for up to 12 months until they complete the study.Subjects requiring additional anti-coagulation therapy who complete their treatment and full 12-month post randomization follow-up or whose treatment is truncated due to the global End of Treatment date will be managed according to local practice.


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STARTRK-2

An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients with Locally Advanced or Metastatic Solid Tumors that Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements

Studie mit Entrectinib zur Behandlung von Patienten mit soliden Tumoren mit NTRK1/2/3, ROS1, or ALK gene fusion.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: 0351/ 4587683


FIRSTMAPPP

First International Randomized Study in Malignant Progressive Pheochromocytoma and Paraganglioma

Ziel der FIRST-MAPPP-Studie ist es, bei Patienten mit einem fortgeschrittenen metastasierten Phäochromozytom oder Paragangliom die Wirksamkeit des neuen Medikamentes Sunitinib beurteilen zu können.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: +49 351 458 7683


REACH2 (CINC424C2301)

A phase III randomized open-label multi-center study of ruxolitinib versus best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation


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Hauptprüfer Dresden: Dr. Friedrich Stölzel
Tel: 2633


JAZZ (15-007)

A Phase 3, Randomized, Adaptive Study Comparing the Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients Undergoing Hematopoietic Stem Cell Transplant


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Hauptprüfer Dresden: Dr. Friedrich Stölzel
Studiensekretariat: Ines Böde Tel: +49 351 4585616


ACE-CL-309

A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator’s Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia


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Hauptprüfer Dresden:
Studiensekretariat: Susann Hollstein Tel: +49 351 4584535


Reach3, CINC424D2301

A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory chronic graft vs host disease after allogenic stem cell transplantation (REACH 3)


Hauptprüfer Dresden: Dr. med. Jan Moritz Middeke
Studiensekretariat: Ines Böde Tel: +49 351 4585616


NCT-MASTER

Körpermaterialstudie: NCT-MASTER Platform Molecularly aided stratification for tumor eradication research

Hauptziele dieser Studie sind die Analyse der genetischen, epigenetischen, proteomischen Veränderungen in individuellen Tumorgeweben sowie die Analytik der zellulären Zusammensetzung. Dies dient der Generierung von Hypothesen zum intelligenten Einsatz neuer zielgerichteter Tumortherapieverfahren, welche spezifisch nur auf die im Tumor nachgewiesenen molekularen Veränderungen ausgerichtet sind und damit eine höhere therapeutische Wirksamkeit bei gleichzeitig geringeren Nebenwirkungen ermöglichen können.


Hauptprüfer Dresden:
Studiensekretariat: Tel: 11750


Gravitas-301

GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease


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Hauptprüfer Dresden: PD Dr. med. Friedrich Stölzel
Studiensekretariat: Ines Böde Tel: +49 351 4585616


Capture

Phase III, randomized, double-blind, multicentre clinical trial on clinical efficacy and safety of platelet concentrates treated with the THERAFLEX UV-Platelets procedure in comparison to conventional platelet components (Capture).


Hauptprüfer Dresden: Dr. Nael Alakel
Studiensekretariat: Christiane Noack Tel: +49 351 4585197


Amyloidose-Register

Nationales klinisches Amyloidose-Register


Hauptprüfer Dresden: Dr. med. Karolin Trautmann-Grill
Tel: 5197


CA209-848

A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)

The purpose of this study is to determine whether nivolumab plus ipilimumab or nivolumab alone is effective and safe in the treatment of solid tumors with High Tumor Mutational Burden (TMB-H)


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Hauptprüfer Dresden:
Studiensekretariat: Tel: 11750


JZP963-201: An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

A Phase 2, Prospective, Randomized, Open-Label Study on the Efficacy of Defibrotide Added to Standard of Care Immunoprophylaxis for the Prevention of Acute Graft-versus-Host-Disease in Adult and Pediatric Patients After Allogeneic Hematopietic Stem Cell Transplant

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.


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Hauptprüfer Dresden:
Studiensekretariat: Tel: +49 351 458 2046


TOP-ART / NCT-PMO-1603

A Randomized Phase-2 Study of Trabectedin/Olaparib Compared to Physician's Choice in Subjects With Previously Treated Advanced or Recurrent Solid Tumors Harboring DNA Repair Deficiencies

Evaluation of the efficacy of the combination of olaparib and trabectedin in adult patients with locally advanced/metastatic solid tumors that failed standard treatment and whose molecular sequencing tumor profiles show homologous recombination repair (HRR) defects. The primary objective is to show superior disease control rate in patients with HRR-deficient tumors treated with olaparib and trabectedin compared to treatment according to current guidelines (physician's choice). This trial aims to establish whether the PARP-dependency of HRR-deficient tumors across entities can be exploited for therapeutic benefit.


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Hauptprüfer Dresden: Dr. med. Stephan Richter
Studiensekretariat: Tel: 0351/ 45811750