Massage Impact on Sleep in Pediatric Oncology
NCT06892158
Acute Lymphoblastic Leukemia, Pediatric, Acute Myeloid Leukemia
Washington D.C., District of Columbia, United States
View Trial DetailsNCT Number: NCT05587049
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Hospital Pablo Tobón Uribe /ID# 248569, Medellín, Antioquia, Colombia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 18 months
OS defined as the time from the date of start Venetoclax to the date of death from any cause.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
DoT defined as the time from the start of a therapy to the time of treatment discontinuation for any reason.
Time frame: Up to 18 Months
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.
Time frame: Up to 18 Months
MRD negativity, defined as having less than 10^-3 residual blasts per leukocyte measured in the bone marrow.
Time frame: Up to 18 Months
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.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
Effectiveness and Safety of Venetoclax in Combination With Azacitidine in Patients With Acute Myeloid Leukemia in Real Life Clinical Practice
Acronym: ESVECO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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