European CML Blast Crisis Register

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03869502

Acronym

BlastCrisis

Enrollment

250

Registered

2019-03-11

Start date

2018-10-25

Completion date

2024-06-30

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia in Myeloid Blast Crisis

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	through study completion in 2024	how many patients survive after a blast crisis event

Secondary

Measure	Time frame	Description
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
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
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

Countries

Czechia, Germany, Russia, Ukraine

Contacts

Primary ContactAnnamaria Brioli, PhD MD

blastcrisis@med.uni-jena.de+49 36419324576

Backup ContactChristian Fabisch, Dr.

blastcrisis@med.uni-jena.de+49 36419396670

Outcome results