An observational study in Chronic Lymphocytic Leukemia, sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie. Completed at 9 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Arbeitsgemeinschaft medikamentoese Tumortherapie · Observational
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.
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.
2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.
This study's enrollment of 472 is above the median of 146 across 215 observational studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.
Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →Arbeitsgemeinschaft medikamentoese Tumortherapie is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All Austrian sites that treat patients in this indication will be invited to participate in this registry.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
General Characteristics
To describe general characteristics of CLL patients
Time frame: 7 years
Genetic Profiling
To describe genetic risk profiles
Time frame: 7 years
Proportion of CLL patients in Austria that require treatment
To describe the proportion of CLL patients in Austria that require treatment
Time frame: 7 years
Number of patients with concomitant diseases
To describe concomitant diseases at diagnosis of CLL
Time frame: 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.
Time frame: 7 years
Patient Outcome
To describe patient outcome (complete response, partial response...) in relation to the type of treatment administered.
Time frame: 7 years
Toxicities
To describe toxicity with a focus on infections, cardiotoxicity, nephrotoxicity, bleeding, etc.
Time frame: 7 years
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Mar 2022 to primary completion in Aug 2026, 52 months.
Of 70 non-industry observational studies under Leukemia, Lymphocytic, Chronic, B-Cell, half reached primary completion within 72 months of starting (the median), counting those still running; a quarter within 30. This study's 52 months is below that.
Counting every sponsor, half of 104 studies reached it within 60 months; a quarter within 32 and three quarters within 176.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 16, 2026: primary completion Dec 2027 → Aug 2026 and completion Dec 2027 → Aug 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Leukemia, Lymphocytic, Chronic, B-Cell →
Arbeitsgemeinschaft medikamentoese Tumortherapie