Actively Recruiting
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia
Led by AbbVie · Updated on 2025-08-08
70
Participants Needed
7
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Assess Change in Disease State in Adult Participants With Acute Myeloid Leukemia (AML) Receiving Oral Venetoclax Tablets in Combination With Subcutaneously (SC) or Intravenously (IV) Injected Azacitidine in Colombia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed acute myeloid leukemia (AML) confirmed by histological criteria, including de novo and secondary AML
- No prior treatment for AML
- Ineligible for intensive chemotherapy due to being 75 years or older, or aged 18 to 74 with health conditions that prevent intensive chemotherapy
- Starting treatment with venetoclax in combination with azacitidine according to Colombia's approved label and have not completed the first 28-day cycle
You will not qualify if you...
- Participating in another interventional clinical trial within 30 days before starting venetoclax treatment
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Hospital Pablo Tobón Uribe /ID# 248569
Medellín, Antioquia, Colombia, 050034
Actively Recruiting
2
Hospital Alma Mater de Antioquia /ID# 248562
Medellin, Bogota D.C., Colombia, 50010
Active, Not Recruiting
3
Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
Valledupar, Cesar Department, Colombia, 200001
Actively Recruiting
4
Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
Bogota DC, Cundinamarca, Colombia, 111221
Active, Not Recruiting
5
Clinica del Country /ID# 248430
Bogota, Cundinamarca, Colombia, 110231
Actively Recruiting
6
Fundación Santa Fé De Bogotá /ID# 248563
Bogotá, Cundinamarca, Colombia, 110111
Actively Recruiting
7
Fundación Valle Del Lili /ID# 248294
Cali, Valle del Cauca Department, Colombia, 760016
Active, Not Recruiting
Research Team
A
Angela Duarte
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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