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BlastCrisis: European CML Blast Crisis Register

Sponsor
University of Jena (Other)
Overall Status
Recruiting
CT.gov ID
NCT03869502
Collaborator
(none)
250
Enrollment
9
Locations
68.2
Anticipated Duration (Months)
27.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    European CML Blast Crisis Register
    Actual Study Start Date :
    Oct 25, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Jun 30, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [through study completion in 2024]

      how many patients survive after a blast crisis event

    Secondary Outcome Measures

    1. Rate of hematologic response to treatment [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 [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 [through study completion in 2024]

      how many patients have blast crisis events compared to all treated CML-patients in the trial centers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Masaryk University Hospital Brno Brno Czechia 62500
    2 Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Dresden Germany 01307
    3 Universitätsklinikum Essen Essen Germany 45147
    4 University Hospital Jena Jena Germany 07747
    5 Universitätsklinikum Leipzig AöR Leipzig Germany 04103
    6 Universitätsmedizin Mannheim Mannheim Germany 68169
    7 Universitaetsklinikum Muenster Münster Germany 48149
    8 I. P. Pavlov First St. Petersburg State Medical University Saint Petersburg Russian Federation 197022
    9 National Research Center for Radiation Medicine Kiev Ukraine 02000

    Sponsors and Collaborators

    • University of Jena

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Annamaria Brioli, Principal Investigator, University of Jena
    ClinicalTrials.gov Identifier:
    NCT03869502
    Other Study ID Numbers:
    • BlastCrisis
    First Posted:
    Mar 11, 2019
    Last Update Posted:
    Jan 29, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leukemia, Myelogenous, Chronic, BCR-ABL Positive
    Blast Crisis

    Study Results

    No Results Posted as of Jan 29, 2021