Chronic Lymphocytic LeukemiaNCT06250465
AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
An observational study of Chronic Lymphocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 9 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 472 participants
- Where
- 9 sitesAustria
- Study dates
- 24 Mar 2022to 4 Aug 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Austrian sites that treat patients in this indication will be invited to participate in this registry.
Who may be able to join
- The registry will include patients ≥ 18 years with CLL.
Who cannot join
- There are no specific exclusion criteria.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Austria9 sites
Landeskrankenhaus Feldkirch, Innere Med. II, Interne E
Feldkirch, 6807
Univ.-Klinik für Innere Medizin V, Hämatologie/Onkologie LKH-Innsbruck / Universitätskliniken
Innsbruck, 6020
A.ö. Bezirkskrankenhaus Kufstein, Innere Medizin / Hämatologie / Onkologie
Kufstein, 6330
KUK Linz: Klinik für Interne 3 - Schwerpunkt Hämatologie und Onkologie
Linz, 4020
Ordensklinikum Linz GmbH - Barmherzige Schwestern; Interne I: Medizinische Onkologie und Hämatologie
Linz, 4020
Ordensklinikum Linz GmbH, Elisabethinen, I. Interne Abteilung Hämato-Onkologie
Linz, 4020
UK Salzburg, LKH: Universitätsklinik für Innere Medizin III
Salzburg, 5020
Univ.-Klinikum St. Pölten, Innere Medizin 1
Sankt Pölten, 3100
Klinikum Wels-Grieskirchen, Abteilung für Innere Medizin IV
Wels, 4600
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Chronic Lymphocytic Leukemia
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
General Characteristics
To describe general characteristics of CLL patients
Measured: 7 years
Genetic Profiling
To describe genetic risk profiles
Measured: 7 years
Proportion of CLL patients in Austria that require treatment
To describe the proportion of CLL patients in Austria that require treatment
Measured: 7 years
Number of patients with concomitant diseases
To describe concomitant diseases at diagnosis of CLL
Measured: 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.
Measured: 7 years
Patient Outcome
To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.
Measured: 7 years
Toxicities
To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start24 Mar 2022
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 472 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen, LP, AstraZeneca, BeiGene
- Responsible party
- Sponsor
- Investigators
- Richard Greil, MD, Principal investigator, AGMT (Austrian Group Medical Tumor Therapy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250465
- Sponsor's protocol ID
- AGMT_CLL-Reg
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated and/or analysed during the current study are not publicly available but are available from AGMT (Austrian Group Medical Tumor Therapy) upon reasonable request. Requests for access to these data should be directed to AGMT via office@agmt.at.
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry
- ClinicalTrials.gov ID
- NCT06250465
- Acronym / sponsor ID
- AGMT_CLL-Reg
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- Arbeitsgemeinschaft medikamentoese TumortherapieUniversity, hospital or other
- Collaborators
- Janssen, LP, AstraZeneca, BeiGene
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Austrian sites that treat patients in this indication will be invited to participate in this registry.
Key inclusion criteria (1 listed)
- The registry will include patients ≥ 18 years with CLL.
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
General Characteristics
Time frame: 7 years
To describe general characteristics of CLL patients
Genetic Profiling
Time frame: 7 years
To describe genetic risk profiles
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
Number of patients with concomitant diseases
Time frame: 7 years
To describe concomitant diseases at diagnosis of CLL
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.
Patient Outcome
Time frame: 7 years
To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.
Toxicities
Time frame: 7 years
To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No. The datasets generated and/or analysed during the current study are not publicly available but are available from AGMT (Austrian Group Medical Tumor Therapy) upon reasonable request. Requests for access to these data should be directed to AGMT via office@agmt.at.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Greil, MD principal investigator
AGMT (Austrian Group Medical Tumor Therapy)
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Arbeitsgemeinschaft medikamentoese Tumortherapie at 9 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Characteristics (time frame: 7 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.