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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Colombia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice
Overview
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.
Primary outcome measures
- Overall Survival (OS) [Time frame: Up to 18 months]
Secondary outcome measures (10)
- Percentage of Participants Achieving Complete Remission (CR) [Time frame: Up to 18 Months]
- Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (Cri) [Time frame: Up to 18 Months]
- Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (CRh) [Time frame: Up to 18 Months]
- Percentage of Participants Achieving Transfusion Independence [Time frame: Up to 18 Months]
- Event-Free Survival (EFS) [Time frame: Up to 18 Months]
- Duration of Remission (DOR) [Time frame: Up to 18 Months]
- Duration of Treatment (DoT) [Time frame: Up to 18 Months]
- Percentage of participants with Adverse Events (AE) [Time frame: Up to 18 Months]
- Percentage of participants achieving Minimal Residual Disease (MRD) negativity [Time frame: Up to 18 Months]
- Change in Health-Related Quality of Life (HRQOL) Score [Time frame: Up to 18 Months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Colombia · 7 centers
- Hospital Pablo Tobón Uribe /ID# 248569 — Medellín
- Hospital Alma Mater de Antioquia /ID# 248562 — Medellin
- Sociedad de Oncologia y Hematologia del Cesar /ID# 248615 — Valledupar
- Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570 — Bogota DC
- Clinica del Country /ID# 248430 — Bogota
- Fundación Santa Fé De Bogotá /ID# 248563 — Bogotá
- Fundación Valle Del Lili /ID# 248294 — Cali
Identifiers
NCT: NCT05587049 · P23-469