UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060501 |
|---|---|
| Receipt number | R000069216 |
| Scientific Title | Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety |
| Date of disclosure of the study information | 2026/01/28 |
| Last modified on | 2026/01/28 17:36:46 |
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Basic information
Public title
Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety
Acronym
Study on venetoclax blood concentration, efficacy, and safety
Scientific Title
Study on the inter-individual variability of venetoclax blood concentrations and its association with efficacy and safety
Scientific Title:Acronym
Study on venetoclax blood concentration, efficacy, and safety
Region
| Japan |
Condition
Condition
Acute Myeloid Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to identify factors contributing to the inter-individual variability of venetoclax trough levels in patients with acute myeloid leukemia (AML). Specifically, we aim to analyze the impact of concomitant medications (such as CYP3A-inhibiting antifungal agents), hepatic and renal function, and patient-specific background factors on venetoclax exposure. The study evaluates the association between trough levels and hematologic toxicities (safety) as well as treatment response rates (efficacy). Through these analyses, we aim to establish evidence-based indices for personalized dosing to optimize efficacy while minimizing the risk of adverse events in actual clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The correlation between venetoclax trough levels and the incidence of hematologic toxicities during the first three treatment cycles
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | JUNYA |
| Middle name | |
| Last name | KANDA |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Hematology
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513152
jkanda16@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | JUNYA |
| Middle name | |
| Last name | KANDA |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Hematology
Zip code
606-8507
Address
4 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513152
Homepage URL
jkanda16@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Kawaharacho, Shogoin, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 17 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective observational (cohort) study of patients receiving venetoclax as part of routine clinical practice. There are no therapeutic interventions or modifications to the standard clinical care or testing schedules for the purposes of this research. The primary focus is to evaluate the correlation between measured venetoclax trough levels and clinical safety and efficacy data.
Management information
Registered date
| 2026 | Year | 01 | Month | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069216
