Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective oral venetoclax is in participants with AML . Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug for treatment of Acute Myeloid Leukemia (AML). Around 600 participants of age 19 years and above will be enrolled in the study in multiple medical institutions across South Korea. Participants will receive oral venetoclax tablets as prescribed by their physician in the routine clinical practice. Participants will be observed for 7 cycles ( each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
OBSERVATIONAL
Enrollment
150
Pusan National University Hospital /ID# 239010
Busan, Busan Gwang Yeogsi, South Korea
Kosin University Gospel Hospital /ID# 257399
Busan, Busan Gwang Yeogsi, South Korea
Kyungpook National University Hospital /ID# 257398
Daegu, Daegu Gwang Yeogsi, South Korea
Gachon University Gil Medical Center /ID# 239008
Incheon, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital /ID# 257478
Hwasun-gun, Jeonranamdo, South Korea
Korea University Anam Hospital /ID# 231022
Seoul, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital /ID# 257477
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 239009
Seoul, Seoul Teugbyeolsi, South Korea
Yeungnam University Medical Center /ID# 239007
Daegu, South Korea
Yonsei University Health System Severance Hospital /ID# 239006
Seoul, South Korea
Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction
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. 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 on or after the first dose of study drug.
Time frame: 32 weeks
Percentage of Participants who Achieved Complete Remission (CR)
The percentage of participants with complete remission (CR) will be calculated based on the modified International Working Group (IWG) criteria for AML.
Time frame: 28 weeks
Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi)
Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
Time frame: 28 weeks
The Percentage of Participants who Achieved Composite Complete Remission (CR+CRi)
Composite Complete Remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol.
Time frame: 28 weeks
Median Time to Achieve Complete Remission [CR] (month)
Time from date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission (in months).
Time frame: 28 weeks
Median Time to Achieve CRi
Time from the date of first oral venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).
Time frame: 28 weeks
Median Overall Survival [OS] (month)
Time from the date of first oral venetoclax intake to the date of death from any cause.
Time frame: 28 weeks
Median Progression Free Survival [PFS] (month)
Median time to achieve Progression Free Survival (PFS) which is the time from \[enrollment or randomization or first dose\] to disease progression or death \[to the first occurrence of radiographic progression determined by blinded independent central review or death from any cause\], whichever occurs first.
Time frame: 28 weeks
Overall Response Rate (ORR) Based on Effectiveness Outcome
Overall Response Rate (ORR) is the proportion of the responders to the total number of participants.
Time frame: 28 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.