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)

August 25, 2023 updated by: AbbVie

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.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Recruiting
        • Pusan National University Hospital /ID# 239010
      • Busan, Korea, Republic of, 49267
        • Recruiting
        • Kosin University Gospel Hospital /ID# 257399
      • Daegu, Korea, Republic of, 42415
        • Completed
        • Yeungnam University Medical Center /ID# 239007
      • Incheon, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Gil Medical Center /ID# 239008
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital /ID# 231022
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center /ID# 239009
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University Health System Severance Hospital /ID# 239006

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
32 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

March 31, 2021

First Submitted That Met QC Criteria

March 31, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-444

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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