Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice

Status: Recruiting
Location: See all (7) locations...
Study Type: Observational
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 adult participants in Colombia. Venetoclax in combination with azacytidine is approved to treat Acute myeloid leukemia (AML). 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 70 participants will be enrolled in the study in Colombia. Participants will receive venetoclax tablets to be taken by mouth in combination with azacitidine given by subcutaneous (SC) or intravenous (IV) injection according to the approved local label. The duration of the study is approximately 36 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Newly diagnosed acute myeloid leukemia (AML) defined as participants that have histological confirmation of AML (de novo, secondary) by World Health Organization (WHO) criteria, and have not received any prior treatment for AML.

• Ineligible to intensive chemotherapy due to \>=75 years of age; or \>=18 to 74 years who have comorbidities that preclude use of intensive induction chemotherapy.

• Participants starting treatment with venetoclax in combination with azacytidine treated according to the Colombia label and who are not completed the first cycle (Cycle 28 days).

Locations
Other Locations
Colombia
Clinica del Country /ID# 248430
RECRUITING
Bogota
Fundación Santa Fé De Bogotá /ID# 248563
RECRUITING
Bogotá
Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
ACTIVE_NOT_RECRUITING
Bogota Dc
Hospital Alma Mater de Antioquia /ID# 248562
ACTIVE_NOT_RECRUITING
Medellin
Hospital Pablo Tobón Uribe /ID# 248569
RECRUITING
Medellín
Fundación Valle Del Lili /ID# 248294
ACTIVE_NOT_RECRUITING
Santiago De Cali
Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
RECRUITING
Valledupar
Contact Information
Primary
Angela Duarte
angela.duarte@abbvie.com
+57 1 638-5000
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2026-11
Participants
Target number of participants: 70
Treatments
Venetoclax + Azacitidine Participants
Participants treated with venetoclax in combination with azacitidine in accordance with approved local label.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov