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 works to treat AML in adult participants who are ineligible for standard induction therapy in Russian Federation. Venetoclax is a drug approved to treat Acute Myeloid Leukemia. All study participants will receive Venetoclax as prescribed by their study doctor in accordance with approved local label. Adult participants with a diagnosis of AML who are ineligible for standard induction therapy will be enrolled. Around 50 participants will be enrolled in the study in approximately 15 sites in Russian Federation. Participants will receive venetoclax tablets to be taken by mouth daily according to the approved local label. The duration of the study is approximately 18 months. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice (approximately every 3 months) and participants will be followed for 18 months.
Study Type
OBSERVATIONAL
Enrollment
51
Moscow State budget healthcare /ID# 218569
Moscow, Moscow, Russia
Saratov State Medical University n.a. V.I. Razumovskiy /ID# 226059
Saratov, Saratov Oblast, Russia
Hematology department State budgetary health care institution Volgograd region /ID# 229813
Volgograd, Volgograd Oblast, Russia
Regional Clinical Hospital of Irkutsk /ID# 218570
Irkutsk, Russia
Clinical Medico-Sanitary Unit #1 /ID# 222502
Perm, Russia
Russian Research Institute of Hematology and Transfusiology of the FMBA /ID# 229812
Saint Petersburg, Russia
R.M.Gorbacheva Research Institute of Paediatric Oncology, Haematology and Transp /ID# 224831
Saint Petersburg, Russia
Almazov National Medical Research Centre /ID# 218571
Saint Petersburg, Russia
Republican Hospital #1 - National Center of Medicine of Sakha (Yakutia) /ID# 224830
Yakutsk, Russia
Sakhalin Regional Clinical Hospital /ID# 222501
Yuzhno-Sakhalinsk, Russia
Overall Survival
Defined as the time (in days) between the date of first Venetoclax intake to date of death.
Time frame: Approximately 18 months
Overall Response Rate
Defined as the percentage of participants with either complete response (CR) or complete response with incomplete hematological recovery (CRi) according to physician's assessment.
Time frame: Approximately 18 months
Best Overall Response Rate
Defined as the percentage of participants with either CR or CRi according to physician's assessment during Venetoclax treatment.
Time frame: Approximately 18 months
Best complete Remission
Defined as the percentage of participants with CR according to physician's assessment during Venetoclax treatment.
Time frame: Approximately 18 months
Time to First Response
Defined as the time (in weeks) between the date of first Venetoclax intake to first response, among CR, CRi, and morphologic leukemia free state (MLSF).
Time frame: Approximately 18 months
Time to Best Response to Treatment
Defined as the time (in weeks) between the date of first Venetoclax intake and the date of hte assessment having documented the best response among CR, CRi, and MLSF.
Time frame: Approximately 18 months
Duration of Response (DOR)
Defined as the time (in weeks) between the date of the first assessment documenting the response to Venetoclax (either CR, CRi, or MLSF) and the date of the first assessment having documented the progression.
Time frame: Approximately 18 months
Event-Free Survival (EFS)
Defined as the time (in weeks) between the date of first Venetoclax intake and the date of the first assessment having documented disease progression (primary refractory disease, or relapse from CR, CRi, or death from any cause).
Time frame: Approximately 18 months
Relapse-Free Survival (RFS)
Defined as the time between the date of CR and the date of the first assessment having documented disease progression or death from any cause.
Time frame: Approximately 18 months
Time to Transfusion Independence
Defined as the time (in weeks) between the date of first Venetoclax intake and the absence of any red blood cell (RBC) or platelet transfusion during any consecutive 8 weeks during the treatment period.
Time frame: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs)
Defined as the percentage of participants treated with Venetoclax in combination with hypomethylating agents (HMAs).
Time frame: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC)
Defined as the percentage of participants treated with Venetoclax in combination with low dose cytarabine (LDAC).
Time frame: Approximately 18 months
Percentage of participants treated with Venetoclax in combination with other therapeutic agents
Defined as the percentage of participants treated with Venetoclax in combination with other therapeutic agents
Time frame: Approximately 18 months
Percentage of participants with dose modifications
Percentage of participants with dose modifications.
Time frame: Approximately 18 months
Percentage of participants with dose interruptions
Percentage of participants with dose interruptions
Time frame: Approximately 18 months
Percentage of participants taking concimtant CYP3A medications
Percentage of participants taking concimtant CYP3A medications while treated with Venetoclax.
Time frame: Approximately 18 months
Number of participants with adverse events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time frame: Approximately 18 months
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