Clinical trial NCT06250465: AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
Official title: AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: All Austrian sites that treat patients in this indication will be invited to participate in this registry.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* There are no specific exclusion criteria.

Primary outcomes:
measure: General Characteristics
timeFrame: 7 years
measure: Genetic Profiling
timeFrame: 7 years
measure: Proportion of CLL patients in Austria that require treatment
timeFrame: 7 years
measure: Number of patients with concomitant diseases
timeFrame: 7 years
measure: Number and type of treatment
timeFrame: 7 years
measure: Patient Outcome
timeFrame: 7 years
measure: Toxicities
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: Landeskrankenhaus Feldkirch, Innere Med. II, Interne E
city: Innsbruck
country: Austria
facility: Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
city: Kufstein
country: Austria
facility: A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
city: Linz
country: Austria
facility: KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
city: Salzburg
country: Austria
facility: UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
city: St.Pölten
country: Austria
facility: Univ.-Klinikum St. Pölten, Innere Medizin 1
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
Study officials:
affiliation: Department of internal Medicine III, Paracelsus Medical University Salzburg, Austria
name: Richard Greil, MD
role: PRINCIPAL_INVESTIGATOR
References: