BlastCrisis = European CML Blast Crisis Register [Czechia, Germany, Russian Federation, Ukraine]

Study title

European CML Blast Crisis Register (BlastCrisis)

Scientific title

European CML Blast Crisis Register (BlastCrisis) (ClinicalTrials.gov NCT03869502)

Type of study

Other trial

Current status

Recruiting

What is the purpose of the study

This is an observational study to collect data from patients with a CML blast crisis, either newly diagnosed or as evolution of a CML in chronic phase. The aim of the registry is to understand this rare condition better.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years and older
  • have been diagnosed with BCR-ABL positive CML blast crisis according to the WHO criteria.
    – Blasts making up 20% or more of white cells in the peripheral blood or bone marrow cells or
    – Increase in the number of blast cells outside of the bone marrow (so-called extramedullary blast formation)
    – Large foci or clusters of blasts in bone marrow biopsy

Patients can be included prospectively or retrospectively if they were treated on or after 01 May 2015.

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.

Estimated primary completion date

June 2024

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov, This is a database provided by the U. S. National Institutes of Health.
You can also find a study description in German on the website of Deutsche CML-Allianz.

Study sponsor

University of Jena, Germany

Scientific lead / contact

Annamaria Brioli, PhD MD
Univerity of Jena, Germany

Principal investigator

Annamaria Brioli, PhD MD
Univerity of Jena, Germany

Study centers / principal investigators

Armenia

Details on study centers will be amended when available

Czechia

Masaryk University Hospital Brno
Brno, 62500
Prof. Dr. Jiri Mayer

France

Details on study centers will be amended when available

Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, 01307
PD Dr. Christoph Röllig

Universitätsklinikum Essen
Essen, 45147
Dr. Joachim R. Göthert

University Hospital Jena
Jena, 07747
Annamaria Brioli, PhD MD

Universitätsklinikum Leipzig AöR
Leipzig, 04103
Dr. Georg-Nikolaus Franke

Universitätsmedizin Mannheim
Mannheim, 68169
Prof. Dr. Susanne Saussele

Universitätsklinikum Münster
Münster, 48149
Prof. Dr. Matthias Stelljes

Italy

Details on study centers will be amended when available

Poland

Details on study centers will be amended when available

 

Russian Federation

I. P. Pavlov First St. Petersburg State Medical University
Saint Petersburg, 197022
Dr. Elena Morozova, PhD

Serbia

Details on study centers will be amended when available

Spain

Details on study centers will be amended when available

Sweden

Details on study centers will be amended when available

Ukraine

National Research Center for Radiation Medicine
Kiev, 02000
Dr. Iryna Dyagil