Trial Title:
AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
NCT ID:
NCT06250465
Condition:
Chronic Lymphocytic Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
All Austrian sites that treat patients in this indication will be invited to participate
in this registry.
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- The registry will include patients ≥ 18 years with CLL.
Exclusion Criteria:
- There are no specific exclusion criteria.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Landeskrankenhaus Feldkirch, Innere Med. II, Interne E
Address:
City:
Feldkirch
Zip:
6807
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Bernd Hartmann, MD
Email:
Principal Investigator
Facility:
Name:
Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Dominik Wolf, MD
Email:
Principal Investigator
Facility:
Name:
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
Address:
City:
Kufstein
Zip:
6330
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
August Zabernigg, MD
Email:
Principal Investigator
Facility:
Name:
KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Clemens Schmitt, MD
Email:
Principal Investigator
Facility:
Name:
Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Manuel Orlinger, MD
Email:
Principal Investigator
Facility:
Name:
Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Thomas Bauer, MD
Email:
Principal Investigator
Facility:
Name:
UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Richard Greil, MD
Email:
Principal Investigator
Facility:
Name:
Univ.-Klinikum St. Pölten, Innere Medizin 1
Address:
City:
St.Pölten
Zip:
3100
Country:
Austria
Status:
Recruiting
Investigator:
Last name:
Petra Pichler, MD
Email:
Principal Investigator
Facility:
Name:
Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
Address:
City:
Wels
Zip:
4600
Country:
Austria
Status:
Recruiting
Contact:
Last name:
Sonja Heibl, MD
Start date:
March 24, 2022
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Agency class:
Other
Source:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06250465
