AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT06250465
- Lead Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Brief Summary
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.
- Detailed Description
This registry is designed as multicenter observational cohort of patients with CLL. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.
For documentation in the registry, no further diagnostic or therapeutic measures are required than those already necessary in general. Participation in the registry must not interfere with treatment routines. Only routine data, which has already been recorded in the patient's medical chart, is transferred to the electronic Case Report Forms. To maintain patient confidentiality, each patient will be assigned a unique patient identifying number upon enrollment; this number will accompany the patient's medical and other registry information throughout the lifetime of the registry.
A written consent must be obtained prior to the input of data. No informed consent is required from deceased patients.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- The registry will include patients ≥ 18 years with CLL.
- There are no specific exclusion criteria.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method General Characteristics 7 years To describe general characteristics of CLL patients
Toxicities 7 years To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.
Genetic Profiling 7 years To describe genetic risk profiles
Patient Outcome 7 years To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.
Proportion of CLL patients in Austria that require treatment 7 years To describe the proportion of CLL patients in Austria that require treatment
Number of patients with concomitant diseases 7 years To describe concomitant diseases at diagnosis of CLL
Number and type of treatment 7 years To describe type and duration of treatment of CLL. Number of patients per treatment, number of treatments per patient.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Landeskrankenhaus Feldkirch, Innere Med. II, Interne E
🇦🇹Feldkirch, Austria
UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
🇦🇹Salzburg, Austria
Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
🇦🇹Innsbruck, Austria
Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
🇦🇹Linz, Austria
Univ.-Klinikum St. Pölten, Innere Medizin 1
🇦🇹St.Pölten, Austria
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
🇦🇹Kufstein, Austria
Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
🇦🇹Linz, Austria
KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie
🇦🇹Linz, Austria
Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
🇦🇹Wels, Austria