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)

Acute Myeloid Leukemia (AML) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04826523
• Other study ID #: P20-444
• Status: Recruiting
• Start date: April 5, 2021
• Est. completion date: November 30, 2025

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 30, 2025
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

--Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.

Exclusion Criteria:

• Participants with contraindications to Venetoclax as listed on the approved local label.

• Participants receiving Venetoclax in clinical trials.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia (AML)
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital /ID# 257398	??	Daegu Gwang Yeogsi
Korea, Republic of	Kosin University Gospel Hospital /ID# 257399	Busan	Busan Gwang Yeogsi
Korea, Republic of	Pusan National University Hospital /ID# 239010	Busan
Korea, Republic of	Yeungnam University Medical Center /ID# 239007	Daegu
Korea, Republic of	Chonnam National University Hwasun Hospital /ID# 257478	Hwasun-gun	Jeonranamdo
Korea, Republic of	Gachon University Gil Medical Center /ID# 239008	Incheon	Gyeonggido
Korea, Republic of	Korea University Anam Hospital /ID# 231022	Seoul
Korea, Republic of	Samsung Medical Center /ID# 239009	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 257477	Seoul
Korea, Republic of	Yonsei University Health System Severance Hospital /ID# 239006	Seoul	Seoul Teugbyeolsi

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	32 weeks
Secondary	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.	28 weeks
Secondary	Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi)	Incomplete regeneration of bone marrow (CRi) as defined in the study protocol.	28 weeks
Secondary	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.	28 weeks
Secondary	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).	28 weeks
Secondary	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).	28 weeks
Secondary	Median Overall Survival [OS] (month)	Time from the date of first oral venetoclax intake to the date of death from any cause.	28 weeks
Secondary	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.	28 weeks
Secondary	Overall Response Rate (ORR) Based on Effectiveness Outcome	Overall Response Rate (ORR) is the proportion of the responders to the total number of participants.	28 weeks

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