Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia

Completed

• Conditions: Acute Myeloid Leukemia (AML)

• Registration Number: NCT04813263
• Lead Sponsor: AbbVie

Brief Summary

Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. 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 to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan.

Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets.

There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-05-28
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

• All participants who are administered venetoclax for treatment of AML.

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML)	Up to 52 weeks.	Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Tumor Lysis Syndrome (TLS)	Up to 52 weeks	Percentage of participants with protocol specified TLS during and after treatment with venetoclax.
Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF)	Up to 52 weeks	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.
Percentage of Participants With Composite Complete Remission Rate (CR + CRi)	Up to 52 weeks	Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria.
Percentage of Participants With Febrile Neutropenia and Thrombocytopenia	Up to 52 weeks	Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.
Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR)	Up to 52 weeks	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.
Median Time to Best Response	Up to 52 weeks.	Time to Best Response is measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.
Median Treatment Duration	Up to 52 weeks	Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.
Median Duration of Composite Complete Remission	Up to 52 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).
Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR)	Up to 52 weeks	Grade 3 and above AE/ADR are serious adverse event (SAE) 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 subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Median Overall Survival	Up to 52 weeks	Time from the date of first oral Venetoclax intake to the date of death from any cause.

Trial Locations

Locations (281)

Anjou Kousei Hospital /ID# 244213; 🇯🇵 Anjo-shi, Aichi, Japan

Nagoya City University Hospital /ID# 256177; 🇯🇵 Nagoya shi, Aichi, Japan

Nagoya City West Medical Center /ID# 250844; 🇯🇵 Nagoya-shi, Aichi, Japan

Aichi Cancer Center Hospital /ID# 243785; 🇯🇵 Nagoya-shi, Aichi, Japan

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital /ID# 242173; 🇯🇵 Nagoya-shi, Aichi, Japan

Nagoya University Hospital /ID# 246009; 🇯🇵 Nagoya-shi, Aichi, Japan

National Center for Geriatrics and Gerontology /ID# 251683; 🇯🇵 Obu-shi, Aichi, Japan

Toyohashi Municipal Hospital /ID# 243784; 🇯🇵 Toyohashi-shi, Aichi, Japan

Toyokawa City Hospital /ID# 242707; 🇯🇵 Toyokawa-shi, Aichi, Japan

Toyota Memorial Hospital /ID# 242175; 🇯🇵 Toyota-shi, Aichi, Japan

Scroll for more (271 remaining)