About this trial
For until very recently CLL has been considered an uncurable disease, with the only few exceptions of a part of patients capable of undergoing and successfully standing allogeneic stem cell transplant. However, the introduction of chemoimmunotherapy in particular the FCR (fludarabine, cyclophosphamide, rituximab) regimen has established a relevant population of IgVH mutated patients, who remain relapse-free for up to 10 years with a clear plateau at this level. However, for the largest proportion of all CLL patients the disease is still associated with a reduction in life expectancy as compared to a matched population.
The field has made further substantial progress by the introduction of BTK inhibitors and Bcl2 inhibitors, novel antibodies as well as by the understanding of the role of minimal residual disease (MRD), mutations and their clonal evolution over time as risk factors and factors governing the kind and duration of therapy.
Due to the limited follow up of frontline therapy trials using novel drugs, it is not yet clear, what the long-term results with many of the new drugs will be. Particularly, long-term PFS, the potential for cure and the long-term safety issues remain relevant parameters requiring examination, as are infections, interactions with other drugs or quality of life issues.
CLL has not been systematically assessed in Austria to date. This medical registry of the AGMT is thus the first Austrian-wide standardized documentation of this disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The registry will include patients ≥ 18 years with CLL.
Disqualifiers
There are no specific exclusion criteria.
Trial population
All Austrian sites that treat patients in this indication will be invited to participate in this registry.
Trial design
Other
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
General Characteristics
To describe general characteristics of CLL patients
Genetic Profiling
To describe genetic risk profiles
Proportion of CLL patients in Austria that require treatment
To describe the proportion of CLL patients in Austria that require treatment
Number of patients with concomitant diseases
To describe concomitant diseases at diagnosis of CLL
Sponsors and contacts
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