European CML Blast Crisis Register (BlastCrisis)

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Myeloid Leukemia in Myeloid Blast Crisis

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Annamaria Brioli, PhD MD; Phone Number: +49 36419324576; Email: blastcrisis@med.uni-jena.de
• Study Contact Backup: Name: Christian Fabisch, Dr.; Phone Number: +49 36419396670; Email: blastcrisis@med.uni-jena.de

Study Locations

• Czechia
  • Brno, Czechia, 62500
    • Recruiting
    • Masaryk University Hospital Brno
    • Contact: Jiri Mayer, Prof. Dr.
• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    • Contact: Christoph Röllig, PD Dr.
  • Essen, Germany, 45147
    • Recruiting
    • Universitätsklinikum Essen
    • Contact: Joachim R. Göthert, Dr.
  • Jena, Germany, 07747
    • Recruiting
    • University Hospital Jena
    • Contact: Annamaria Brioli, PhD MD; Phone Number: +49 36419324576; Email: blastcrisis@med.uni-jena.de
  • Leipzig, Germany, 04103
    • Recruiting
    • Universitätsklinikum Leipzig AöR
    • Contact: Georg-Nikolaus Franke, Dr.
  • Mannheim, Germany, 68169
    • Recruiting
    • Universitätsmedizin Mannheim
    • Contact: Susanne Saussele, Prof. Dr.
  • Münster, Germany, 48149
    • Recruiting
    • Universitaetsklinikum Muenster
    • Contact: Matthias Stelljes, Prof. Dr.
• Russian Federation
  • Saint Petersburg, Russian Federation, 197022
    • Recruiting
    • I. P. Pavlov First St. Petersburg State Medical University
    • Contact: Elena Morozova, PhD Dr.
• Ukraine
  • Kiev, Ukraine, 02000
    • Recruiting
    • National Research Center for Radiation Medicine
    • Contact: Iryna Dyagil, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	how many patients survive after a blast crisis event	through study completion in 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Jena
• Investigators: Principal Investigator: Annamaria Brioli, PhD MD, Univerity of Jena

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Neoplastic Processes; Leukemia; Cell Transformation, Neoplastic; Carcinogenesis; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Blast Crisis
• Other Study ID Numbers: BlastCrisis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No