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

Acute Myeloid Leukemia Clinical Trial

— ESVECO  

Official title:

Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587049
• Other study ID #: P23-469
• Status: Recruiting
• Start date: November 16, 2023
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: Angela Duarte
• Phone: +57 1 638-5000
• Email: angela.duarte[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Colombia	Clinica del Country /ID# 248430	Bogota	Cundinamarca
Colombia	Fundacion Santa Fe de Bogota /ID# 248563	Bogota	Cundinamarca
Colombia	Coorp Hosp Juan Ciudad Sede Hospital Universitario Mayor Mederi /ID# 248570	Bogota DC	Cundinamarca
Colombia	Fundacion Valle Del Lili /ID# 248294	Cali	Valle Del Cauca
Colombia	Hospital Alma Mater de Antioquia /ID# 248562	Medellin	Distrito Capital De Bogota
Colombia	Hospital Pablo Tobón Uribe /ID# 248569	Medellín
Colombia	Sociedad de Oncologia y Hematologia del Cesar /ID# 248615	Valledupar	Cesar

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS defined as the time from the date of start Venetoclax to the date of death from any cause.	Up to 18 months
Secondary	Percentage of Participants Achieving Complete Remission (CR)	CR is defined according to the modified International Working Group (IWG) criteria for acute myeloid leukemia (AML) as no morphologic evidence of AML and absolute neutrophil count >=10^3 /µL (>=1.0 x 10^9 /L), platelets >=10^5 /µL (>=100 x 10^9 /L), red blood cell (RBC) transfusion independence, and bone marrow with <5% blasts. Absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease.	Up to 18 Months
Secondary	Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (Cri)	Cri is defined according to the modified IWG criteria for AML as all criteria as CR except for residual neutropenia <10^3 /µL (1,000/ µL), or thrombocytopenia <10^5 /µL (100,000/ µL). If all criteria for CR are meet except for RBC transfusion independence, this also fulfills Cri criteria.	Up to 18 Months
Secondary	Percentage of Participants Achieving Complete Remission with Incomplete Marrow Recovery (CRh)	CRh is defined according to the modified IWG criteria for AML as bone marrow with < 5% blasts and Peripheral blood neutrophil count of > 0.5 × 10^3 /µL and Peripheral blood platelet count of > 0.5 × 10^5 /µL and 1-week (>= 7 days) platelet transfusion-free period prior to the hematology lab collection.	Up to 18 Months
Secondary	Percentage of Participants Achieving Transfusion Independence	Transfusion ndependence is defined as a period of at least 56 days with no transfusion between the first dose of Venetoclax and the last dose of Venetoclax plus 30 days.	Up to 18 Months
Secondary	Event-Free Survival (EFS)	EFS defined as the time from the date of start Venetoclax to the date of morphologic relapse, progressive disease, resistant disease, treatment failure, or death from any cause.	Up to 18 Months
Secondary	Duration of Remission (DOR)	DOR defined as the time from the date of first CR, CRi or CRh to the earliest evidence of morphologic relapse, progressive disease, or death due to disease progression.	Up to 18 Months
Secondary	Duration of Treatment (DoT)	DoT defined as the time from the start of a therapy to the time of treatment discontinuation for any reason.	Up to 18 Months
Secondary	Percentage of participants with Adverse Events (AE)	AE, defined as any unfavorable medical event that is temporarily related to the use of the investigational product, which does not necessarily have a causal relationship with the investigational product.	Up to 18 Months
Secondary	Percentage of participants achieving Minimal Residual Disease (MRD) negativity	MRD negativity, defined as having less than 10^-3 residual blasts per leukocyte measured in the bone marrow.	Up to 18 Months
Secondary	Change in Health-Related Quality of Life (HRQOL) Score	HRQOL score, defined as a multidimensional construct defined as the subjective perception of the life as a whole, including physical, emotional, social, cognitive functions, disease symptoms and side effects of treatment.	Up to 18 Months

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