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
Multicentric prospective and retrospective register collecting patient with CML blast crisis diagnosed in Germany and Europe
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.
361 studies on the registry are indexed under Blast Crisis; 16 are open to participants now.
This study's planned enrollment of 250 is above the median of 168 across 25 observational studies indexed under Blast Crisis.
Browse Blast Crisis studies →University of Jena is the lead sponsor of 89 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with CML Blast crisis, either newly diagnosed or as evolution of a CML in chronic phase
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diagnosis of BCR-ABL positive CML blast crisis according to the WHO criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Overall survival
how many patients survive after a blast crisis event
Time frame: through study completion in 2024
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
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
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
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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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