AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

NCT ID: NCT06250465

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2027-12-31

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.

Conditions

Chronic Lymphocytic Leukemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arbeitsgemeinschaft medikamentoese Tumortherapie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Greil, MD

Role: PRINCIPAL_INVESTIGATOR

Department of internal Medicine III, Paracelsus Medical University Salzburg, Austria

Locations

Landeskrankenhaus Feldkirch, Innere Med. II, Interne E

Feldkirch, , Austria

Site Status: RECRUITING

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

Innsbruck, , Austria

Site Status: RECRUITING

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

Kufstein, , Austria

Site Status: RECRUITING

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

Linz, , Austria

Site Status: RECRUITING

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

Linz, , Austria

Site Status: RECRUITING

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

Linz, , Austria

Site Status: RECRUITING

UK Salzburg, LKH: Universitätsklinik für Innere Medizin III

Salzburg, , Austria

Site Status: RECRUITING

Univ.-Klinikum St. Pölten, Innere Medizin 1

Sankt Pölten, , Austria

Site Status: RECRUITING

Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV

Wels, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Daniela Wolkersdorfer

Role: CONTACT

office@agmt.at

+43 662 640 44 12

Facility Contacts

Sonja Heibl, MD

Role: primary

Other Identifiers

AGMT_CLL-Reg

Identifier Type: -

Identifier Source: org_study_id