Trials / Active Not Recruiting
Active Not RecruitingNCT06058741
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
Venetoclax Real-World Observational Study on Effectiveness and Treatment Management in Patients With Newly Diagnosed AML Who Are Ineligible for Intensive Chemotherapy in Italy
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 works to treat AML in newly diagnosed adult participants who are ineligible for intensive chemotherapy in Italy. Venetoclax in combination with azacitidine is approved in Italy to treat Acute myeloid leukemia (AML) in newly diagnosed adults who are ineligible for intensive chemotherapy. All study participants will receive venetoclax in combination with azacitidine as prescribed by their study doctor in accordance with approved local label. Adult participants with a new diagnosis of AML will be enrolled. Around 150 participants will be enrolled in the study at approximately 20-25 sites in Italy. Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) injection according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 18 months.
Conditions
Timeline
- Start date
- 2024-03-04
- Primary completion
- 2026-11-01
- Completion
- 2026-11-01
- First posted
- 2023-09-28
- Last updated
- 2025-04-22
Locations
28 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT06058741. Inclusion in this directory is not an endorsement.