Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety

Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety - Study on venetoclax blood concentration, efficacy, and safety

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000060501

Enrollment

100

Registered

2026-01-28

Start date

2021-05-17

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who are receiving or have received venetoclax. Patients diagnosed with acute myeloid leukemia. Patients aged 18 years or older at the time of enrollment. Patients who have received a sufficient explanation regarding the study and provided written informed consent from themselves or their legal representative.

Exclusion criteria

Exclusion criteria: Patients with poor medication adherence Patients receiving venetoclax monotherapy or combination therapy with agents other than azacitidine Patients whose venetoclax dose was not adjusted appropriately according to concomitant medications, such as CYP3A inhibitors.

Design outcomes

Primary

Measure	Time frame
The correlation between venetoclax trough levels and the incidence of hematologic toxicities during the first three treatment cycles	—

Secondary

Measure	Time frame
Identification of factors contributing to the inter-individual variability of venetoclax trough levels. Correlation between venetoclax trough levels and treatment response rates. Association between venetoclax trough levels and overall survival (OS). Correlation between venetoclax trough levels and the incidence of non-hematologic adverse events of Grade >=3. Correlation between the area under the concentration-time curve (AUC) and trough levels of venetoclax.	—

Measure

Time frame

Identification of factors contributing to the inter-individual variability of venetoclax trough levels. Correlation between venetoclax trough levels and treatment response rates. Association between venetoclax trough levels and overall survival (OS). Correlation between venetoclax trough levels and the incidence of non-hematologic adverse events of Grade >=3. Correlation between the area under the concentration-time curve (AUC) and trough levels of venetoclax.

—

Countries

Japan

Contacts

Public ContactJUNYA KANDA

Graduate School of Medicine, Kyoto University Department of Hematology

jkanda16@kuhp.kyoto-u.ac.jp0757513152

Outcome results