MedTrace Logo

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

NCT06058741 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-04-22

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06058741 on ClinicalTrials.gov