Clinical trial 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
Official title: Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Venetoclax
Venclexta
Venclyxto
Azacitidine
ABT-199
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-10-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed AML participants who are ineligible to intensive chemotherapy, that starting treatment with Venetoclax in combination with azacytidine treated according to the Colombia label.

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.


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.

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 18 months
Secondary outcomes:
measure: Percentage of Participants Achieving Complete Remission (CR)
timeFrame: Up to 18 Months
measure: Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (Cri)
timeFrame: Up to 18 Months
measure: Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (CRh)
timeFrame: Up to 18 Months
measure: Percentage of Participants Achieving Transfusion Independence
timeFrame: Up to 18 Months
measure: Event-Free Survival (EFS)
timeFrame: Up to 18 Months
measure: Duration of Remission (DOR)
timeFrame: Up to 18 Months
measure: Duration of Treatment (DoT)
timeFrame: Up to 18 Months
measure: Percentage of participants with Adverse Events (AE)
timeFrame: Up to 18 Months
measure: Percentage of participants achieving Minimal Residual Disease (MRD) negativity
timeFrame: Up to 18 Months
measure: Change in Health-Related Quality of Life (HRQOL) Score
timeFrame: Up to 18 Months
Other outcomes:
Locations:
city: Valledupar
country: Colombia
facility: Sociedad de Oncologia y Hematologia del Cesar /ID# 248615
state: Cesar
city: Bogota DC
country: Colombia
facility: Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570
state: Cundinamarca
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota /ID# 248563
state: Cundinamarca
city: Bogota
country: Colombia
facility: Clinica del Country /ID# 248430
state: Cundinamarca
city: Medellin
country: Colombia
facility: Hospital Alma Mater de Antioquia /ID# 248562
state: Distrito Capital De Bogota
city: Cali
country: Colombia
facility: Fundacion Valle Del Lili /ID# 248294
state: Valle Del Cauca
city: Medellín
country: Colombia
facility: Hospital Pablo Tobón Uribe /ID# 248569
state: Valle Del Cauca
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: