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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Greil, MD, Department of internal Medicine III, Paracelsus Medical University Salzburg, Austria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Lymphocytic Leukemia

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