AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250465
• Other study ID #: AGMT_CLL-Reg
• Status: Recruiting
• Start date: March 24, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: Daniela Wolkersdorfer
• Phone: +43 662 640 44 12
• Email: office[@]agmt.at
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• There are no specific exclusion criteria.

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Feldkirch, Innere Med. II, Interne E	Feldkirch
Austria	Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken	Innsbruck
Austria	A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie	Kufstein
Austria	KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie	Linz
Austria	Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie	Linz
Austria	Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie	Linz
Austria	UK Salzburg, LKH: Universitätsklinik für Innere Medizin III	Salzburg
Austria	Univ.-Klinikum St. Pölten, Innere Medizin 1	St.Pölten
Austria	Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV	Wels

Sponsors (1)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	General Characteristics	To describe general characteristics of CLL patients	7 years
Primary	Genetic Profiling	To describe genetic risk profiles	7 years
Primary	Proportion of CLL patients in Austria that require treatment	To describe the proportion of CLL patients in Austria that require treatment	7 years
Primary	Number of patients with concomitant diseases	To describe concomitant diseases at diagnosis of CLL	7 years
Primary	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
Primary	Patient Outcome	To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.	7 years
Primary	Toxicities	To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.	7 years