Status:
RECRUITING
Observational Study Relapsed or Refractory Chronic Lymphocytic Leukemia Venetoclax-based Regimens Outside Clinical Trials in Italy
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Chronic Lymphocytic Leukemia
Relapse Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
Observational study aimed at describing the characteristics and outcome of CLL patients who started treatment with venetoclax-based regimens according to the local label outside clinical trials in Ita...
Detailed Description
Observational study to describe the characteristics and outcome of CLL patients treated with venetoclax according to the local label. The study includes two different groups: a retrospective group (al...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients with R/R CLL fulfilling the eligibility criteria required by the Venetoclax Named Patient Program who have received at least 1 dose of venetoclax.
- Patients with CLL who have received at least 1 dose of venetoclax or are scheduled to start treatment with venetoclax according to the Post-marketing Use before June 30th, 2025.
- Signed informed consent document (if feasible) according to ICH/EU/GCP and national local laws indicating that the patients understand the purpose of the study and they agree to give complete access to their medical records.
- Exclusion Criteria:
- None
Exclusion
Key Trial Info
Start Date :
July 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT04282811
Start Date
July 24 2020
End Date
October 31 2025
Last Update
January 17 2025
Active Locations (27)
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1
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Ferrara, Italy
2
Aon Ss. Antonio E Biagio E C. Arrigo - Alessandria - Soc Ematologia
Alessandria, Italy
3
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, Italy
4
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, Italy