Assessing the effectiveness of venetoclax and azacitidine for treating acute myeloid leukemia in adults
Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice
This study is testing if a combination of venetoclax tablets and azacitidine injections can help adults with newly diagnosed acute myeloid leukemia feel better and improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Medellín, Antioquia and 6 other locations) |
| Trial ID | NCT05587049 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a new diagnosis of acute myeloid leukemia who are ineligible for intensive chemotherapy.
Not a fit: Patients who have received prior treatment for AML or are participating in another interventional clinical trial may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could improve outcomes for patients with acute myeloid leukemia who are not candidates for intensive chemotherapy.
How similar studies have performed: Previous studies have shown that the combination of venetoclax and azacitidine is effective in treating acute myeloid leukemia, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Medellín, Antioquia and 6 other locations
- Hospital Pablo Tobón Uribe /ID# 248569 — Medellín, Antioquia, Colombia (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 (Recruiting)
- Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570 — Bogota DC, Cundinamarca, Colombia (Active_not_recruiting)
- Clinica del Country /ID# 248430 — Bogota, Cundinamarca, Colombia (Recruiting)
- Fundación Santa Fé De Bogotá /ID# 248563 — Bogotá, Cundinamarca, Colombia (Recruiting)
- Fundación Valle Del Lili /ID# 248294 — Cali, Valle del Cauca Department, Colombia (Active_not_recruiting)
Study contacts
- Study coordinator: Angela Duarte
- Email: angela.duarte@abbvie.com
- Phone: +57 1 638-5000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.