ASCANY Register (CABL001ADE01R) [Germany]
Study title
ASCANY Register
Scientific title
German prospective observational study for patients with chronic myeloid leukemia (CML) previously treated with ≥ 2 TKIs switched to asciminib or any ATP-competitive TKI
Type of study
Patient registry
Current status
Recruiting
Other trial ID
CABL001ADE01R
What is the purpose of the study
Tyrosine kinase inhibitors (TKIs) are a group of drugs used for the treatment of CML and are the standard therapy for CML. Asciminib, the sixth TKI, was approved for the treatment of CML in 2022. TKIs differ mainly in terms of their most common side effects, and in some cases also in terms of efficacy and possible use.
This is a registry to document which TKIs are used in patients (age, gender, concomitant diseases, etc.) for further treatment, and how effective and tolerable these TKI are. The data collected is hoped to provide information on CML patients’ perceptions on how the therapy used affects their everyday lives (impairments due to side effects, etc.).
What will happen during the study
Participation in the registry will not affect participants’ medical treatment. Additional visits to the clinic/practice are not necessary. The data collected during the treatment of CML will be recorded for a period of three years.
Key inclusion criteria
This study includes patients who:
- are adult patients (male or female) with Philadelphia chromosome positive or BCR::ABL1-fusion gene positivee chronic myeloid leukemia (CML) in chronic phase, without T315I mutation
- have been previously treated with ≥ 2 TKIs
- are going to be or have been switched to an approved third-line TKI as determined by the treating physician.
- will be or have been switched due to “warning” or “failure” (in line with the ELN recommendations from 2020) or due to intolerability to the last TKI
- are/were aged 18 years and older at the time of switching to third or higher line therapy
- have given their written informed consent to participate in this registry (although data will be collected prospectively, patients can still be included if they were switched to third or higher line therapy within 9 months of giving informed consent)
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This registry does not include patients who:
- do not give their informed consent to participating
- are currently being treated in an interventional clinical trial
- have evidence of a T315I mutation.
Where can I find additional information
Study sponsor
University of Heidelberg in collaboration with Novartis Pharma GmbH
Scientific lead / contact
Prof. Dr. Susanne Saußele
University of Heidelberg, Germany
Principal investigator
Dr. Katharina Kohlbrenner
University of Heidelberg, Germany
Study centers / principal investigators
Germany
Aachen
Uniklinikum RWTH Aachen
Aschaffenburg
MVZ am Klinikum Aschaffenburg (Dr. Welslau)
Augsburg
Universitätsklinikum Augsburg
Berlin
Charité Berlin
Berlin
OnkoBerlin (Prof. Dr. Josting)
Berlin
MVZ Berlin Mitte (Dr. Fuhrmann, Dr. Schabath)
Bonn
Johanniter-Krankenhaus und Waldkrankenhaus Bonn
Dachau /Donauwörth
ONKOMEDEOR Onkologische Zentren (Prof. Dr. Hempel)
Dresden
Onkozentrum Dresden/Freiberg/Meißen (Dr. Göhler, Dr. Dörfel, Dr. Boldt, Dr. Hering)
Dresden
Fachärztliche Gemeinschaftspraxis (Dres. Freiberg-Richter, Jacobasch, Illmer, Wolf)
Düsseldorf
Marienhospital Düsseldorf
Gießen
UKGM – Universitätsklinikum Gießen und Marburg
Goslar
MVZ Onkologische Kooperation Harz
Gütersloh
Onkodok Gütersloh (Dr. Depenbusch, Dr. Schütt, Dr. Sonnenberg)
Hannover
Onkologisches Studienzentrum am Raschplatz (Dr. Zander /Dr. von der Heyde)
Hannover
Onkologisches Ambulanzzentrum (OAZ) (Dr. Ehlers, Dr. Rodewig, Dr. Gärtner, Dr. Hauser)
Heidelberg
Onkologische Schwerpunktpraxis Heidelberg (Dr. Fuxius, Dr. Debatin)
Hildesheim
St. Bernward Krankenhaus Hildesheim
Jena
Universitätsklinikum Jena
Kempten
Klinikum Kempten
Köln
Onko Köln (Dr. Weber)
Mannheim
Universitätsmedizin Mannheim
München
MVZ Hämatologie und Onkologie München Pasing (Dr. Schmidt, Dr. Zingerle, Dr. Harwix)
Passau
MVZ Passau (Dr. Sandner)
Potsdam
Schwerpunktpraxis für Hämatologie und Onkologie (Dr. Gerhardt, Dr. Linde)
Rostock
Universitätsmedizin Rostock
Schwetzingen, Weinheim, Wiesloch
ze:ro-Praxen (specialized in oncology)
Sindelfingen
Kliniken Sindelfingen and MVZ
Trier
Klinikum Mutterhaus Trier
Ulm
Universitätsklinikum Ulm
Winnenden
Rems-Murr-Kliniken