Acute Myeloid Leukemia (AML)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)
An observational study of Acute Myeloid Leukemia (AML), run by AbbVie at 10 sites in South Korea.
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 . Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- How many people
- 150 participants
- Where
- 10 sitesSouth Korea
- Study dates
- 5 Apr 2021to 20 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- --Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.
Who cannot join
- Participants with contraindications to Venetoclax as listed on the approved local label.
- Participants receiving Venetoclax in clinical trials.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
South Korea10 sites
Pusan National University Hospital /ID# 239010
Busan, Busan Gwang Yeogsi, 49241
Kosin University Gospel Hospital /ID# 257399
Busan, Busan Gwang Yeogsi, 49267
Kyungpook National University Hospital /ID# 257398
Daegu, Daegu Gwang Yeogsi, 41944
Yeungnam University Medical Center /ID# 239007
Daegu, 42415
Chonnam National University Hwasun Hospital /ID# 257478
Hwasun-gun, Jeonranamdo, 58128
Gachon University Gil Medical Center /ID# 239008
Incheon, Gyeonggido, 21565
Korea University Anam Hospital /ID# 231022
Seoul, Seoul Teugbyeolsi, 02841
Seoul National University Hospital /ID# 257477
Seoul, Seoul Teugbyeolsi, 03080
Samsung Medical Center /ID# 239009
Seoul, Seoul Teugbyeolsi, 06351
Yonsei University Health System Severance Hospital /ID# 239006
Seoul, 03722
About this study
Official title: Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients
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.
Read more
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.
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia (AML), AML, Venetoclax, Venclexta, Venclyxto, Cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants treated with Venetoclax | Participants who were prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) will be enrolled for this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 32 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 28 weeks
Median Overall Survival [OS] (month)
Time from the date of first oral venetoclax intake to the date of death from any cause.
Measured: 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.
Measured: 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.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start5 Apr 2021
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826523
- Sponsor's protocol ID
- P20-444
- Status last verified
- Nov 2025
- First submitted
- 31 Mar 2021
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venetoclax (Venclexta Tablet) Post-Marketing Surveillance for AML Patients
- ClinicalTrials.gov ID
- NCT04826523
- Acronym / sponsor ID
- P20-444
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute Myeloid Leukemia (AML), AML, Venetoclax, Venclexta, Venclyxto, Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants treated with Venetoclax | – | –Participants who were prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) will be enrolled for this study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- --Acute Myeloid Leukemia (AML) participants who have been prescribed oral Venetoclax tablets for the first time according to the approved label.
Key exclusion criteria (2 listed)
- Participants with contraindications to Venetoclax as listed on the approved local label.
- Participants receiving Venetoclax in clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction
Time frame: 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.
8 secondary outcomes
Percentage of Participants who Achieved Complete Remission (CR)
Time frame: 28 weeks
Percentage of Participants who Achieved Complete Remission With Incomplete Hematologic Recovery (CRi)
Time frame: 28 weeks
The Percentage of Participants who Achieved Composite Complete Remission (CR+CRi)
Time frame: 28 weeks
Median Time to Achieve Complete Remission [CR] (month)
Time frame: 28 weeks
Median Time to Achieve CRi
Time frame: 28 weeks
Median Overall Survival [OS] (month)
Time frame: 28 weeks
Median Progression Free Survival [PFS] (month)
Time frame: 28 weeks
Overall Response Rate (ORR) Based on Effectiveness Outcome
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Related infoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML), run by AbbVie at 10 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Reported Serious Adverse Event/Drug Reaction (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.