AGMT Austrian CLL (Chronic Lymphocytic Leukemia) Registry

StatusCompleted
PhaseNot specified
Started

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Record History

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  1. Minor Trial completed Show 5 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2027 to Aug 4, 2026
    • Enrollment target: estimated 500 to confirmed 472
    • Site details revised at 9 of 9 sites
    • Eligibility criteria expanded, about 2 words
    • Collaborators expanded, about 4 words
  2. Minor Site contacts updated at 1 of 9 sitesv3
  3. Notable Primary endpoints revised (7)
    • Site details revised at 4 of 9 sites
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06250465
Lead Sponsor Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators: Janssen, LP, AstraZeneca, BeiGene
Conditions
(from sponsor)
Chronic Lymphocytic Leukemia
Related terms Leukemia, Lymphocytic, Chronic, B-Cell
Enrollment 472 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov