NCT05587049Recruiting
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
Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 18 Oct 2022
- Start date
- 30 Nov 2023
- Primary completion date
- Nov 2026
- Lead sponsor
- AbbVie
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT05587049
What you commit to
- Study type: Observational
- Planned participants: 70
- From 30 Nov 2023 to the primary completion date, Nov 2026
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica del Country /ID# 248430 Coordinator of this site? Confirm its status | Bogota | Colombia | Recruiting |
| Fundacion Santa Fe De Bogota /ID# 248563 Coordinator of this site? Confirm its status | Bogota | Colombia | Recruiting |
| Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570 Coordinator of this site? Confirm its status | Bogota DC | Colombia | Active, not recruiting |
| Fundacion Valle Del Lili /ID# 248294 Coordinator of this site? Confirm its status | Cali | Colombia | Active, not recruiting |
| FOSCAL International /ID# 287252 Coordinator of this site? Confirm its status | Floridablanca | Colombia | Active, not recruiting |
| Hospital Alma Mater de Antioquia /ID# 248562 Coordinator of this site? Confirm its status | Medellin | Colombia | Active, not recruiting |
| Hospital Pablo Tobon Uribe /ID# 248569 Coordinator of this site? Confirm its status | Medellín | Colombia | Active, not recruiting |
| Sociedad de Oncologia y Hematologia del Cesar /ID# 248615 Coordinator of this site? Confirm its status | Valledupar | Colombia | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.