Status:
ACTIVE_NOT_RECRUITING
A Study to Asses Effectiveness and Treatment Management of Oral Venetoclax Tablets + Subcutaneously Injected Azacitidine in Adult Participants Ineligible for Intensive Chemotherapy With de Novo Acute Myeloid Leukemia (AML) in Italy
Lead Sponsor:
AbbVie
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Brief Summary
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common acute leukemia in adults. This study will evaluate how well venetoclax in combination with azacitidine work...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of primary or secondary acute myeloid leukemia (AML), deemed ineligible for intensive induction chemotherapy because of age, performance status, comorbidities or any other clinical reason as defined by the treating physician.
- Investigator decision on patient treatment with venetoclax + azacitidine must have been reached prior to and independently of recruitment in the study.
- Treatment prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies.
Exclusion
- Participants affected by Acute Promyelocytic Leukemia.
- Prior treatment for AML, excluding hydroxyurea.
- Participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. Participation in another post-marketing observational study or Registry is acceptable
Key Trial Info
Start Date :
March 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06058741
Start Date
March 4 2024
End Date
November 1 2026
Last Update
April 22 2025
Active Locations (28)
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1
Presidio Ospedaliero Vito Fazzi /ID# 261222
Lecce, Apulia, Italy, 73100
2
Azienda Ospedaliero Universitaria Careggi /ID# 259766
Florence, Firenze, Italy, 50134
3
Ospedale San Martino /ID# 258981
Genoa, Genova, Italy, 16132
4
IRCCS Istituto Clinico Humanitas /ID# 259300
Rozzano, Lombardy, Italy, 20089