AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Last updated: April 9, 2025
Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Platelet Disorders

Lymphocytic Leukemia, Chronic

Lymphoproliferative Disorders

Treatment

N/A

Clinical Study ID

NCT06250465
AGMT_CLL-Reg
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • There are no specific exclusion criteria.

Study Design

Total Participants: 500
Study Start date:
March 24, 2022
Estimated Completion Date:
December 31, 2027

Study 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.

Connect with a study center

  • Landeskrankenhaus Feldkirch, Innere Med. II, Interne E

    Feldkirch, 6807
    Austria

    Active - Recruiting

  • Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie

    Kufstein, 6330
    Austria

    Active - Recruiting

  • KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie

    Linz, 4020
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie

    Linz, 4020
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie

    Linz, 4020
    Austria

    Active - Recruiting

  • UK Salzburg, LKH: Universitätsklinik für Innere Medizin III

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Univ.-Klinikum St. Pölten, Innere Medizin 1

    St.Pölten, 3100
    Austria

    Active - Recruiting

  • Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV

    Wels, 4600
    Austria

    Active - Recruiting

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