UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047371 |
|---|---|
| Receipt number | R000053971 |
| Scientific Title | Pharmacokinetic analysis of venetoclax and treatment outcome in patients with acute myelogenous leukemia |
| Date of disclosure of the study information | 2022/04/02 |
| Last modified on | 2022/04/02 15:45:24 |
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Basic information
Public title
Pharmacokinetic analysis of venetoclax and treatment outcome in patients with acute myelogenous leukemia
Acronym
Pharmacokinetic analysis of venetoclax and treatment outcome in patients with acute myelogenous leukemia
Scientific Title
Pharmacokinetic analysis of venetoclax and treatment outcome in patients with acute myelogenous leukemia
Scientific Title:Acronym
Pharmacokinetic analysis of venetoclax and treatment outcome in patients with acute myelogenous leukemia
Region
| Japan |
Condition
Condition
acute myelogenous leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the relevance between the blood concentration of venetoclax and its therapeutic effects in patients with AML
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To examine the relevance between the blood concentration of venetoclax and treatment response, such as CR rate and duration of response
Key secondary outcomes
To examine the relevance between the blood concentration of venetoclax and adverse events (hematological AEs, tumor-lysis syndrome, infections)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed as having AML and treated with regimes including venetoclax at least for 1 week.
2) 20 years old or older.
3) Agree with ICF.
Key exclusion criteria
1) Disagree with ICF.
2) Patients who lack medical adherence.
3) Patients who are otherwise considered ineligible for the study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kondo |
Organization
Aiiku Hospital
Division name
Blood Disorders Center
Zip code
064-0804
Address
South 4 West 25, Chuo-ku, Sapporo
TEL
+81-11-563-2211
kondo@aiiku-hp.or.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Kondo |
Organization
Aiiku Hospital
Division name
Blood Disorders Center
Zip code
064-0804
Address
South 4 West 25, Chuo-ku, Sapporo
TEL
+81-11-563-2211
Homepage URL
kondo@aiiku-hp.or.jp
Sponsor or person
Institute
Aiiku Hospital Blood Disorders Center
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Pharmacy, University of Tsukuba Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The institutional review boards of Aiiku Hospital
Address
South 4 West 25, Chuo-ku, Sapporo
Tel
+81-11-563-2211
aiiku-rinri@aiiku-hp.or.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
| 2022 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 04 | Month | 02 | Day |
Last modified on
| 2022 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053971
