Assessing the effectiveness of venetoclax and azacitidine for treating acute myeloid leukemia in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of venetoclax tablets combined with azacitidine injections in treating adult patients with newly diagnosed acute myeloid leukemia (AML) in Colombia. Participants will receive these medications as prescribed by their doctors, following local guidelines. The study aims to enroll around 70 participants and will monitor their disease state over approximately 36 months. There is no additional burden on participants, as all visits will coincide with routine care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

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

Where it's running

• Fundacion Santa Fe De Bogota /ID# 248563
  Bogota, Cundinamarca, Colombia Recruiting
• Clinica del Country /ID# 248430
  Bogota, Cundinamarca, Colombia Recruiting
• Hospital Pablo Tobon Uribe /ID# 248569
  Medellín, Antioquia, Colombia Active not recruiting
• Hospital Alma Mater de Antioquia /ID# 248562
  Medellin, Bogota D.C., Colombia Active not recruiting
• Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
  Valledupar, Cesar Department, Colombia Completed
• Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
  Bogota DC, Cundinamarca, Colombia Active not recruiting

Study contacts

• Study coordinator: Angela Duarte
• Email: angela.duarte@abbvie.com
• Phone: +57 1 638-5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.