AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• General Characteristics [Срок оценки: 7 years]
• Genetic Profiling [Срок оценки: 7 years]
• Proportion of CLL patients in Austria that require treatment [Срок оценки: 7 years]
• Number of patients with concomitant diseases [Срок оценки: 7 years]
• Number and type of treatment [Срок оценки: 7 years]
• Patient Outcome [Срок оценки: 7 years]
• Toxicities [Срок оценки: 7 years]

Критерии участия

Критерии включения

• The registry will include patients ≥ 18 years with CLL.

Критерии исключения

• There are no specific exclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Австрия · 9 центров

• 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
• … и ещё 1 центр

Идентификаторы

NCT: NCT06250465 · AGMT_CLL-Reg

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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