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
NCT ID: NCT05587049
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
70 participants
OBSERVATIONAL
2023-11-30
2026-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Venetoclax + Azacitidine Participants
Participants treated with venetoclax in combination with azacitidine in accordance with approved local label.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Hospital Pablo Tobón Uribe /ID# 248569
Medellín, Antioquia, Colombia
Hospital Alma Mater de Antioquia /ID# 248562
Medellin, Bogota D.C., Colombia
Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
Valledupar, Cesar Department, Colombia
Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
Bogota DC, Cundinamarca, Colombia
Clinica del Country /ID# 248430
Bogota, Cundinamarca, Colombia
Fundación Santa Fé De Bogotá /ID# 248563
Bogotá, Cundinamarca, Colombia
Fundación Valle Del Lili /ID# 248294
Cali, Valle del Cauca Department, Colombia
Countries
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Central Contacts
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Related Links
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Related info
Other Identifiers
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P23-469
Identifier Type: -
Identifier Source: org_study_id
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