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European CML Blast Crisis Register (BlastCrisis)

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ClinicalTrials.gov Identifier: NCT03869502
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Annamaria Brioli, University of Jena

Study Description
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Brief Summary:
Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe

Condition or disease
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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: European CML Blast Crisis Register
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: through study completion in 2024 ]
    how many patients survive after a blast crisis event


Secondary Outcome Measures :
  1. Rate of hematologic response to treatment [ Time Frame: through study completion in 2024 ]
    how many patients have a hematologic response to the local standard Treatment after a blast crisis event

  2. Rate of molecular response to treatment [ Time Frame: through study completion in 2024 ]
    how many patients have a molecular response to the local standard Treatment after a blast crisis event

  3. Rate of blast crises in Europe in the era of TKI treatment [ Time Frame: through study completion in 2024 ]
    how many patients have blast crisis events compared to all treated CML-patients in the trial centers


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869502


Contacts
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Contact: Annamaria Brioli, PhD MD +49 36419324576 blastcrisis@med.uni-jena.de
Contact: Christian Fabisch, Dr. +49 36419396670 blastcrisis@med.uni-jena.de

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

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Responsible Party: Annamaria Brioli, Principal Investigator, University of Jena
ClinicalTrials.gov Identifier: NCT03869502    
Other Study ID Numbers: BlastCrisis
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Blast Crisis
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
Cell Transformation, Neoplastic
Carcinogenesis
Neoplastic Processes
Pathologic Processes