Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants Above 19 Years of Age With Acute Myeloid Leukemia (AML)

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04826523

Collaborator

(none)

600

Enrollment

Location

55.9

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML)

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients

Actual Study Start Date :

Apr 5, 2021

Anticipated Primary Completion Date :

Nov 30, 2025

Anticipated Study Completion Date :

Nov 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Participants treated with Venetoclax Participants who were prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) will be enrolled for this study.

Outcome Measures

Primary Outcome Measures

Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction [32 weeks]
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.

Secondary Outcome Measures

Percentage of Participants who Achieved Complete Remission (CR) [28 weeks]
The percentage of participants with complete remission (CR) will be calculated based on the modified International Working Group (IWG) criteria for AML.
Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi) [28 weeks]
Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.
The Percentage of Participants who Achieved Composite Complete Remission (CR+CRi) [28 weeks]
Composite Complete Remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol.
Median Time to Achieve Complete Remission [CR] (month) [28 weeks]
Time from date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission (in months).
Median Time to Achieve CRi [28 weeks]
Time from the date of first oral venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).
Median Overall Survival [OS] (month) [28 weeks]
Time from the date of first oral venetoclax intake to the date of death from any cause.
Median Progression Free Survival [PFS] (month) [28 weeks]
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.
Overall Response Rate (ORR) Based on Effectiveness Outcome [28 weeks]
Overall Response Rate (ORR) is the proportion of the responders to the total number of participants.