AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chronic Lymphocytic Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- General Characteristics [Time frame: 7 years]
- Genetic Profiling [Time frame: 7 years]
- Proportion of CLL patients in Austria that require treatment [Time frame: 7 years]
- Number of patients with concomitant diseases [Time frame: 7 years]
- Number and type of treatment [Time frame: 7 years]
- Patient Outcome [Time frame: 7 years]
- Toxicities [Time frame: 7 years]
Eligibility criteria
Inclusion criteria
- The registry will include patients ≥ 18 years with CLL.
Exclusion criteria
- There are no specific exclusion criteria.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Austria · 9 centers
- Landeskrankenhaus Feldkirch, Innere Med. II, Interne E — Feldkirch
- Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätsklini — Innsbruck
- A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie — Kufstein
- KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie — Linz
- Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und H — Linz
- Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie — Linz
- UK Salzburg, LKH: Universitätsklinik für Innere Medizin III — Salzburg
- Univ.-Klinikum St. Pölten, Innere Medizin 1 — Sankt Pölten
- … and 1 more center
Identifiers
NCT: NCT06250465 · AGMT_CLL-Reg