Actively Recruiting

Age: 18Years +
All Genders
NCT05587049

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

Led by AbbVie · Updated on 2025-08-08

70

Participants Needed

7

Research Sites

152 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newly diagnosed acute myeloid leukemia (AML) confirmed by histological criteria, including de novo and secondary AML
  • No prior treatment for AML
  • Ineligible for intensive chemotherapy due to being 75 years or older, or aged 18 to 74 with health conditions that prevent intensive chemotherapy
  • Starting treatment with venetoclax in combination with azacitidine according to Colombia's approved label and have not completed the first 28-day cycle
Not Eligible

You will not qualify if you...

  • Participating in another interventional clinical trial within 30 days before starting venetoclax treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Hospital Pablo Tobón Uribe /ID# 248569

Medellín, Antioquia, Colombia, 050034

Actively Recruiting

2

Hospital Alma Mater de Antioquia /ID# 248562

Medellin, Bogota D.C., Colombia, 50010

Active, Not Recruiting

3

Sociedad de Oncologia y Hematologia del Cesar /ID# 248615

Valledupar, Cesar Department, Colombia, 200001

Actively Recruiting

4

Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570

Bogota DC, Cundinamarca, Colombia, 111221

Active, Not Recruiting

5

Clinica del Country /ID# 248430

Bogota, Cundinamarca, Colombia, 110231

Actively Recruiting

6

Fundación Santa Fé De Bogotá /ID# 248563

Bogotá, Cundinamarca, Colombia, 110111

Actively Recruiting

7

Fundación Valle Del Lili /ID# 248294

Cali, Valle del Cauca Department, Colombia, 760016

Active, Not Recruiting

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Research Team

A

Angela Duarte

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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