ASCANY Register [Germany]

Study title

ASCANY Register

Scientific title

German prospective registry for patients with chronic myeloid leukemia (CML) who were previously treated with ≥ 2 TKIs and switched to another TKI

Type of study

Patient registry

Current status

Recruiting

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.

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

Aschaffenburg
MVZ am Klinikum Aschaffenburg

Berlin
Charité Berlin

Bonn
Johanniter-Krankenhaus und Waldkrankenhaus Bonn

Dachau
Onkologisches Zentrum Dachau

Dresden
Onkozentrum Dresden

Goslar
MVZ Onkologische Kooperation Harz

Hannover
Onkologisches Studienzentrum am Raschplatz

Hannover
Onkologisches Ambulanzzentrum (OAZ)

Heidelberg
Onkologie Heidelberg

Hildesheim
St. Bernward Krankenhaus Hildesheim

Jena
Universitätsklinikum Jena

Kempten
Klinikum Kempten

Mannheim
Universitätsmedizin Mannheim

München
MVZ Hämatologie und Onkologie München Pasing

Trier
Klinikum Mutterhaus Trier

Ulm
Universitätsklinikum Ulm