AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Lymphocytic Leukemia

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Daniela Wolkersdorfer; Phone Number: +43 662 640 44 12; Email: office@agmt.at

Study Locations

• Austria
  • Feldkirch, Austria, 6807
    • Recruiting
    • Landeskrankenhaus Feldkirch, Innere Med. II, Interne E
    • Principal Investigator: Bernd Hartmann, MD
  • Innsbruck, Austria, 6020
    • Recruiting
    • Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
    • Principal Investigator: Dominik Wolf, MD
  • Kufstein, Austria, 6330
    • Recruiting
    • A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
    • Principal Investigator: August Zabernigg, MD
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
    • Principal Investigator: Thomas Bauer, MD
  • Linz, Austria, 4020
    • Recruiting
    • KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie
    • Principal Investigator: Clemens Schmitt, MD
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
    • Principal Investigator: Manuel Orlinger, MD
  • Salzburg, Austria, 5020
    • Recruiting
    • UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
    • Principal Investigator: Richard Greil, MD
  • St.Pölten, Austria, 3100
    • Recruiting
    • Univ.-Klinikum St. Pölten, Innere Medizin 1
    • Principal Investigator: Petra Pichler, MD
  • Wels, Austria, 4600
    • Recruiting
    • Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
    • Contact: Sonja Heibl, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• There are no specific exclusion criteria.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Investigators: Principal Investigator: Richard Greil, MD, Department of internal Medicine III, Paracelsus Medical University Salzburg, Austria

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 25, 2022
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid
• Other Study ID Numbers: AGMT_CLL-Reg

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No