European CML Blast Crisis Register

Chronic Myeloid Leukemia in Myeloid Blast Crisis Clinical Trial

— BlastCrisis  

Official title:

European CML Blast Crisis Register

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03869502
• Other study ID #: BlastCrisis
• Status: Recruiting
• Start date: October 25, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2023
• Source: University of Jena
• Contact: Annamaria Brioli, PhD MD
• Phone: +49 36419324576
• Email: blastcrisis[@]med.uni-jena.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

Description:

Since the advent of treatment with tyrosine kinase inhibitors (TKI), the incidence of blast crises has significantly decreased. Nevertheless, about 5% of patients diagnosed with chronic myeloid leukemia (CML) will evolve into a blast phase at some point during the course of their disease. Furthermore, despite the advances made in CML treatment, outcome of patients with blast crises are still dismal. Due to the rarity of this condition clinical trials are challenging, and collaboration between researchers both at national and international level is needed to collect a meaningful number of data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years
• Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:
• Blasts 20% or more of peripheral blood white cells or bone marrow cells or
• Extramedullary blast proliferation or
• Large foci or clusters of blasts in bone marrow biopsy

Exclusion Criteria:

• Lack of informed consent

Related Conditions & MeSH terms

• Blast Crisis
• Chronic Myeloid Leukemia in Myeloid Blast Crisis
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Locations

Country	Name	City	State
Czechia	Masaryk University Hospital Brno	Brno
Germany	Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Essen	Essen
Germany	University Hospital Jena	Jena
Germany	Universitätsklinikum Leipzig AöR	Leipzig
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Universitaetsklinikum Muenster	Münster
Russian Federation	I. P. Pavlov First St. Petersburg State Medical University	Saint Petersburg
Ukraine	National Research Center for Radiation Medicine	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Countries where clinical trial is conducted

Czechia,  Germany,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	how many patients survive after a blast crisis event	through study completion in 2024
Secondary	Rate of hematologic response to treatment	how many patients have a hematologic response to the local standard Treatment after a blast crisis event	through study completion in 2024
Secondary	Rate of molecular response to treatment	how many patients have a molecular response to the local standard Treatment after a blast crisis event	through study completion in 2024
Secondary	Rate of blast crises in Europe in the era of TKI treatment	how many patients have blast crisis events compared to all treated CML-patients in the trial centers	through study completion in 2024