Clinical trial NCT04826523: 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)
Official title: Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute Myeloid Leukemia (AML)
AML
Venetoclax
Venclexta
Venclyxto
Cancer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-04-01
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute Myeloid Leukemia (AML) participants who are prescribed Venetoclax within the approved label shall be enrolled in the study according to the clinical judgment of the physician in charge of the study.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction
timeFrame: 32 weeks
Secondary outcomes:
measure: Percentage of Participants who Achieved Complete Remission (CR)
timeFrame: 28 weeks
measure: Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi)
timeFrame: 28 weeks
measure: The Percentage of Participants who Achieved Composite Complete Remission (CR+CRi)
timeFrame: 28 weeks
measure: Median Time to Achieve Complete Remission [CR] (month)
timeFrame: 28 weeks
measure: Median Time to Achieve CRi
timeFrame: 28 weeks
measure: Median Overall Survival [OS] (month)
timeFrame: 28 weeks
measure: Median Progression Free Survival [PFS] (month)
timeFrame: 28 weeks
measure: Overall Response Rate (ORR) Based on Effectiveness Outcome
timeFrame: 28 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital /ID# 257399
state: Busan Gwang Yeogsi
city: 중구
country: Korea, Republic of
facility: Kyungpook National University Hospital /ID# 257398
state: Daegu Gwang Yeogsi
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center /ID# 239008
state: Gyeonggido
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 257478
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 239006
state: Seoul Teugbyeolsi
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital /ID# 239010
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center /ID# 239007
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital /ID# 231022
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 257477
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 239009
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: