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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief 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

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

Study ID: NCT05587049

Interventions

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sociedad de Oncologia y Hematologia del Cesar /ID# 248615, Valledupar, Cesar, Colombia

Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570, Bogota DC, Cundinamarca, Colombia

Fundacion Santa Fe de Bogota /ID# 248563, Bogota, Cundinamarca, Colombia

Clinica del Country /ID# 248430, Bogota, Cundinamarca, Colombia

Hospital Alma Mater de Antioquia /ID# 248562, Medellin, Distrito Capital De Bogota, Colombia

Fundacion Valle Del Lili /ID# 248294, Cali, Valle Del Cauca, Colombia

Hospital Pablo Tobón Uribe /ID# 248569, Medellín, , Colombia

Contact Details

Name: ABBVIE INC.

Affiliation: AbbVie

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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