RecruitingNCT05587049

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

Sponsor

AbbVie

Enrollment

70 participants

Start Date

Nov 30, 2023

Study Type

OBSERVATIONAL

Conditions

Acute Myeloid Leukemia

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

Min Age: 18 Years

Inclusion Criteria3

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).

Exclusion Criteria1

\- Participating in an interventional clinical trial within 30 days prior to Venetoclax treatment initiation.

Locations(7)

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

View Full Details on ClinicalTrials.gov

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NCT05587049

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