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RecruitingNCT03869502BlastCrisisUpdated May 10, 2023

European CML Blast Crisis Register

An observational study in Chronic Myeloid Leukemia in Myeloid Blast Crisis, sponsored by University of Jena. Recruiting at 9 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by University of Jena · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Chronic Myeloid Leukemia in Myeloid Blast Crisis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • Lack of informed consent
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
250 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Overall survival

    how many patients survive after a blast crisis event

    Time frame: through study completion in 2024

Secondary outcomes

  1. Rate of hematologic response to treatment

    how many patients have a hematologic response to the local standard Treatment after a blast crisis event

    Time frame: through study completion in 2024

  2. Rate of molecular response to treatment

    how many patients have a molecular response to the local standard Treatment after a blast crisis event

    Time frame: through study completion in 2024

  3. 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

    Time frame: through study completion in 2024

06

Study locations

9 of 9 sites recruiting
  • Masaryk University Hospital Brno
    Brno, 62500, Czechia
    • Jiri Mayer, Prof. Dr. · Contact
    Recruiting
  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
    Dresden, 01307, Germany
    • Christoph Röllig, PD Dr. · Contact
    Recruiting
  • Universitätsklinikum Essen
    Essen, 45147, Germany
    • Joachim R. Göthert, Dr. · Contact
    Recruiting
  • University Hospital Jena
    Jena, 07747, Germany
    Recruiting
  • Universitätsklinikum Leipzig AöR
    Leipzig, 04103, Germany
    • Georg-Nikolaus Franke, Dr. · Contact
    Recruiting
  • Universitätsmedizin Mannheim
    Mannheim, 68169, Germany
    • Susanne Saussele, Prof. Dr. · Contact
    Recruiting
  • Universitaetsklinikum Muenster
    Münster, 48149, Germany
    • Matthias Stelljes, Prof. Dr. · Contact
    Recruiting
  • I. P. Pavlov First St. Petersburg State Medical University
    Saint Petersburg, 197022, Russian Federation
    • Elena Morozova, PhD Dr. · Contact
    Recruiting
  • National Research Center for Radiation Medicine
    Kiev, 02000, Ukraine
    • Iryna Dyagil, Dr. · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No — A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03869502
Lead sponsor
University of Jena
Responsible party
Annamaria Brioli (Principal Investigator, University of Jena) — Principal investigator
First posted
Mar 11, 2019
Start date
Oct 25, 2018
Primary completion
Jun 30, 2024 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
May 10, 2023

Study contacts

Annamaria Brioli, PhD MD
Contact
blastcrisis@med.uni-jena.de
+49 36419324576
Christian Fabisch, Dr.
Contact
blastcrisis@med.uni-jena.de
+49 36419396670
Annamaria Brioli, PhD MD
principal investigator · Univerity of Jena

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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