AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

NCT06250465 | Recruiting

• 1 other identifier: AGMT_CLL-Reg
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Lymphocytic Leukemia

Outcome Measures

Primary Outcomes (7)

• General Characteristics

  To describe general characteristics of CLL patients

  7 years

• Genetic Profiling

  To describe genetic risk profiles

  7 years

• Proportion of CLL patients in Austria that require treatment

  To describe the proportion of CLL patients in Austria that require treatment

  7 years

• Number of patients with concomitant diseases

  To describe concomitant diseases at diagnosis of CLL

  7 years

• Number and type of treatment

  To describe type and duration of treatment of CLL. Number of patients per treatment, number of treatments per patient.

  7 years

• Patient Outcome

  To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.

  7 years

• Toxicities

  To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.

  7 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All Austrian sites that treat patients in this indication will be invited to participate in this registry.

You may qualify if:

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

Sponsors & Collaborators

• Arbeitsgemeinschaft medikamentoese Tumortherapie: lead

Study Sites (9)

Landeskrankenhaus Feldkirch, Innere Med. II, Interne E

Feldkirch, 6807, Austria

RECRUITING

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

Innsbruck, 6020, Austria

RECRUITING

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

Kufstein, 6330, Austria

RECRUITING

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

Linz, 4020, Austria

RECRUITING

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

Linz, 4020, Austria

RECRUITING

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

Linz, 4020, Austria

RECRUITING

UK Salzburg, LKH: Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

RECRUITING

Univ.-Klinikum St. Pölten, Innere Medizin 1

Sankt Pölten, 3100, Austria

RECRUITING

Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV

Wels, 4600, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The CLL registry will be accompanied by an optional biobanking program. Sample collection will be limited to patients that have signed an additional biobanking IC. The samples are taken as part of the clinical routine.

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard Greil, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Wolkersdorfer

CONTACT

+43 662 640 44 12; office@agmt.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: February 9, 2024
• Study Start: March 24, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (9)