For Clinical Research Organisations (CROs)

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Overview

Our Early Clinical Trials Unit Leipzig (ECTUL) is embedded in an network of specialized institutions with a long lasting record in all aspects of cancer related research:

  • Leipzig University as one of the highly ranked German universities offers the access to a diverse cluster of basic and translational research including preclinical cancer and stem cell aspects
  • The University Hospital Leipzig belongs to the top 10 German hospitals in the 2021 national "Focus" healthcare ranking with top scoring in various pathologies including leukemia, colon cancer, nuclear medicine, radiotherapy
  • Our University Hospital comprises over 1400 hospital beds and over 4600 employees
  • The ECTUL (Early Clinical Trials Unit Leipzig) as interdisciplinary center multiplies medical and particularly oncologic research opportunities combined with an optimal treatment of patients with various malignant conditions
  • The interdisciplinary cooperation offers in- and outpatient treatment facilities in addition to various kinds of tumor boards for an optimal treatment of the patients
  • The team of the study unit consisting of study nurses, study assistants and coordinators, all GCP-trained, supports the clinical trials and ensures trial conduct according to highest national and international quality standards. They assume responsibility in the field of database-, (e)CRF-management and clinical monitoring
  • The Clinical Trial Centre Leipzig acts as scientific partner and service provider for physicians and scientists of the University Hospital Leipzig. It supports both academic-initiated and commercial trials and assists sponsors and investigating scientists.

Structure

The ECTUL is nationally and internationally collaborating facility. The cooperative team comprising committed physicians, study nurses and administrative staff is experienced and regularly trained in the successful realization of clinical trials of all phases. In addition, phase I experienced principal investigators are specialized in hematologic cancers. We have strong and successful collaborations with:

    • An accredited central laboratory (certified according to DIN EN ISO/IEC 17025:2018, DIN EN 13612 and directive 98/79/EG) offering comprehensive services 24 hours 7 days
    • A GMP pharmacy, regularly certified according to DIN EN ISO 9001:2015, licensed for German Drug Law (AMG) for production, blinding, randomization, (re-)packaging and distribution of clinical investigational products
    • Manufacturing plant HEAL for resource-friendly production and development of clinical trial samples. Technical features includes GMP (good manufacturing practice) compliant rooms for sterile, aseptic, for parenteral nutrition and for cytostatic drugs production as well as genetic engineering facility safety level 2.
    • Nationally and internationally recognized professionals with comprehensive knowledge of malignant hematologic and solid diseases attracting patients from all over Germany
    • Participation within the Study Alliance Leukemia (SAL)
    • Specialized scientists of the Fraunhofer Insitute for Cell Therapy and Immunology (IZI)
    • Member of the D-MDS (Deutsche MDS Studiengruppe) and EMSCO (European Myelodysplastic Syndromes Cooperative Group)
    • Various registries for hematologic diseases (e.g. European Mantle Cell Lymphoma Network, registry for multiple myeloma, paroxysmal nocturnal hemoglobinuria (PNH) registry)
    • Interdisciplinary collaboration with internal departments such as UCCL (Leipzig University Cancer Center), dermatology, ear-nose-throat department
    • Close cooperation with private practice oncologists and hematologists​

Setting

The ECTUL is a central early clinical trial unit for the conduct of phase-I/II clinical trials, including First-in-Human clinical trials. Primary goal is to evaluate the safety, tolerability and efficacy of new investigational therapies. The ECTUL is open to all medical departments of the University Hospital Leipzig as well as the cooperating partners and offers innovative therapeutic options for patients.

Due to the ECTUL translational research possibilities are multiplied at the University Hospital Leipzig. It provides a platform for innovative medicine in an interdisciplinary setting.

We use an electronic data management system for documentation and organization of treatment appointments for all patients enabling an optimal link between in- and outpatient treatment.

The ECTUL consists of two double rooms equipped with bed-side monitoring to comply with regulatory guidelines of European and German authorities for First-in-Human trials. It is possible to centrally monitor and control cardiac functions and other vital parameters to accommodate safety assessments and measures.

We are currently providing two rooms for patient treatment comprising two intensive care beds in each room with intensive care monitoring, separate bathroom, WLAN- and TV-services. Two additional rooms will be expanded in near future, thus providing eight beds. To ensure an optimal inpatient treatment the rooms are integrated in the stationary hematologic care offering 24 hours / 7 days medical surveillance and specialized nurse care. The ECTUL is localized next to the intensive care unit to assure immediate emergency measures as needed. In addition, relevant examining departments are localized within the building, such as cardiology, radiology and pulmonology. A 24 hours / 7 days emergency hotline guarantees rapid assistance for ambulatory patients in need.

Furthermore, room for storage of study documents and samples as well as processing of trial samples with calibrated and certified devices like centrifuge, freezer and fridge is available within the ward. The fridge (4°C) and freezer (-20°C and -80°C​) are connected to a central surveillance system and emergency power system.

For the visit of monitors and auditors various rooms equipped with computer, WLAN and printers are available.​


Staff

The ECTUL is led by PD Dr. med. Sabine Kayser as well as Professor Dr. med. Uwe Platzbecker, director of the Medical Clinic and Policlinic 1. The interdisciplinary cooperative team is specialized and trained for safety- and risk-management, but also for individual demands of early clinical protocols as well as national and international good clinical practice (GCP) standards. In addition, the medical professionals are regularly trained in basic and advanced life support.

The effective conduct of clinical trials within the ECTUL is guaranteed by a dedicated team of physicians, study nurses, study coordinators, study assistances and documentarists, all GCP trained with diverse focus of activities. A fixed contact person accompanies all phases of a research project and coordinates the necessary activities.

Responsibilities of the staff members of the clinical trials unit:

Study coordinator

  • Start-up coordination and negotiation
  • Communication with ethics committee and local authorities
  • Compilation of essential documents for submission to authorities
  • prepares the clinical trial treatment plans in accordance to the SOP
  • calculates the billings of study visit services
  • Coordination of patients' visits within the trial
  • Preparation and collection of SI/PI signed study-related documents
  • Trial medication logistics

Study assistance

  • Realization of patient visits including study laboratory values, electrocardiograms, reimbursement of travel expenses, output via IP, maintenance of patient files​

Documentarist

  • Preparation and maintenance of patient study files
  • Documentation in patient study file and eCRF according to ALCOA-CCEA principle

Pictures

Entrance to ECTUL:​


Patient room:

Office ECTUL:

Working Station with fridge, freezer and centrifuge:



Contract Management

​​To ensure an effective and smooth implementation of your clinical study we guarantee a timely contract processing. You can send the contract drafts for our medical and legal review in German, English or bilingual.

  • Fixed contact person for contract management
  • Organization and coordination of necessary contract processing with all involved partners
  • Separate contracts for our pharmacy

We provide a flexible, uncomplicated and timely contract processing.

Phase I Trial Record (selection)

​Inidication​Phase​Mechanism of action​Compound​Clinical trial
​​AML1​​antibodymonoclonal anti-CD70-antibody​​74494550AML1003
AML / MM​1 / 2​T cells​PRAME TCR-modified T cells​CD-TCR-001
​NHL / MDS​1small molecule inhibitor​​inhibitor of protein arginine methyltransferase 5 (PRMT5)64619178EDI1001​
​NHL​1 / 2​CAR-T cells​chimeric antigen receptor T cell (CAR-T) therapy​M-2016-312
MDS / AML​​1small molecule inhibitor​small molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4)CA-4948-102​
​MPN​1 / 2small molecule inhibitorsmall molecule inhibitor​ of bromodomain and extra-terminal (BET) proteins​0610-02 MANIFEST​
Gastric cancer​1antibody​​​half-life extended (HLE) BiTE® (bispecific T cell engager) antibody construct​(AMG 910) 20180292

Contact

​​PD Dr. med. Sabine Kayser

Universitätsklinikum Leipzig
ECTUL
Medizinische Klinik und Poliklinik 1
Universitätsklinikum Leipzig
Liebigstr. 20, Haus 4
04103 Leipzig

E-Mail:  ectul@medizin.uni-leipzig.de
Studieneinheit: 0341-97 12634
Sekretariat: 0341 - 97 13050

Liebigstr. 20 und 22, Johannisallee 32a, Haus 4 und 7, Haus 9
04103 Leipzig
Telefon:
0341 - 97 13050
Telefon:
0341 - 97 13081 (Hämatologische Ambulanz)
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