Chronic Myeloid Leukemia in Myeloid Blast CrisisBlastCrisisNCT03869502
European CML Blast Crisis Register
An observational study of Chronic Myeloid Leukemia in Myeloid Blast Crisis, run by University of Jena at 9 sites in 4 countries.
Trial summary
Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia in Myeloid Blast Crisis
- How many people
- 250 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 25 Oct 2018to 30 Jun 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase
Who may be able to join
- 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
Who cannot join
- Lack of informed consent
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Germany6 sites, 6 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden
Dresden, 01307
Christoph Röllig, PD Dr.
- Recruiting
Universitätsklinikum Essen
Essen, 45147
Joachim R. Göthert, Dr.
- Recruiting
University Hospital Jena
Jena, 07747
Annamaria Brioli, PhD MD, +49 36419324576, blastcrisis@med.uni-jena.de
- Recruiting
Universitätsklinikum Leipzig AöR
Leipzig, 04103
Georg-Nikolaus Franke, Dr.
- Recruiting
Universitätsmedizin Mannheim
Mannheim, 68169
Susanne Saussele, Prof. Dr.
- Recruiting
Universitaetsklinikum Muenster
Münster, 48149
Matthias Stelljes, Prof. Dr.
Czechia1 site, 1 recruiting
- Recruiting
Masaryk University Hospital Brno
Brno, 62500
Jiri Mayer, Prof. Dr.
Russia1 site, 1 recruiting
- Recruiting
I. P. Pavlov First St. Petersburg State Medical University
Saint Petersburg, 197022
Elena Morozova, PhD Dr.
Ukraine1 site, 1 recruiting
- Recruiting
National Research Center for Radiation Medicine
Kiev, 02000
Iryna Dyagil, Dr.
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
how many patients survive after a blast crisis event
Measured: through study completion in 2024
Secondary outcomes (3)
Rate of hematologic response to treatment
how many patients have a hematologic response to the local standard Treatment after a blast crisis event
Measured: 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
Measured: 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
Measured: through study completion in 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start25 Oct 2018
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid Leukemia in Myeloid Blast CrisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annamaria Brioli, University of Jena
- Investigators
- Annamaria Brioli, PhD MD, Principal investigator, Univerity of Jena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869502
- Sponsor's protocol ID
- BlastCrisis
- Acronym
- BlastCrisis
- Status last verified
- May 2023
- First submitted
- 7 Mar 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European CML Blast Crisis Register
- ClinicalTrials.gov ID
- NCT03869502
- Acronym / sponsor ID
- BlastCrisis / BlastCrisis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe
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
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase
Key inclusion criteria (5 listed)
- Age >18 years
- Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:
Key exclusion criteria (1 listed)
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: through study completion in 2024
how many patients survive after a blast crisis event
3 secondary outcomes
Rate of hematologic response to treatment
Time frame: through study completion in 2024
Rate of molecular response to treatment
Time frame: through study completion in 2024
Rate of blast crises in Europe in the era of TKI treatment
Time frame: through study completion in 2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: No. A joint publication is planned. But no data of trial Centers will be shared with the other trial centers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annamaria Brioli, PhD MD principal investigator
Univerity of Jena
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia in Myeloid Blast Crisis, run by University of Jena at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Czechia, Russia, Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annamaria Brioli, PhD MD (+49 36419324576, blastcrisis@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: through study completion in 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.