UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050247 |
|---|---|
| Receipt number | R000057222 |
| Scientific Title | Real-world experience of venetoclax for patients with newly diagnosed acute myeloid leukemia in Japan: a Multicenter Observational Study |
| Date of disclosure of the study information | 2023/02/06 |
| Last modified on | 2025/01/08 13:12:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Real-world experience of venetoclax for patients with newly diagnosed acute myeloid leukemia in Japan: a Multicenter Observational Study
Acronym
VENUS study
Scientific Title
Real-world experience of venetoclax for patients with newly diagnosed acute myeloid leukemia in Japan: a Multicenter Observational Study
Scientific Title:Acronym
VENUS study
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 describe the treatment outcome with VEN plus AZA or LDAC in terms of OS of patients with newly diagnosed Intensive chemotherapy ineligible AML in the real-world setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome
1.Overall survival (OS)
Key secondary outcomes
Secondary outcome:
1.Event-free survival (EFS)
2.Response rate, time to first response, duration of response (DoR)
3.Time course of blood cell counts
4.Healthcare resource utilization (transfusion, supportive care, hospitalization/outpatient visits)
5.Treatment patterns
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
1.Patients aged 18 or older at the time of conducting the study.
2.Patients newly diagnosed with Intensive chemotherapy ineligible AML and treated with VEN plus AZA or low-dose Ara-C (LDAC).
3. Patients who started treatment with VEN between June 23, 2021 and September 30, 2022.
Key exclusion criteria
1.Patients who explicitly declines the use of data for this study.
2.Patients who received prior lines of therapy for AML. (Note that patients treated with AZA for MDS will be included in this study)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsunori |
| Middle name | |
| Last name | Goto |
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
Division name
Hematology
Zip code
453-8511
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya City, Aichi Prefecture
TEL
052-481-5111
prj-venus-jimu@eps.co.jp
Public contact
Name of contact person
| 1st name | Mizuha |
| Middle name | |
| Last name | Kanaya |
Organization
AbbVie GK
Division name
Oncology, Medical Affairs, Medical
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo 108-0023, Japan
TEL
03-4577-1111
Homepage URL
mizuha.kanaya@abbvie.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital Research Ethics Committee
Address
3-35 Michishita-cho, Nakamura-ku, Nagoya City, Aichi Prefecture
Tel
052-481-5111
rinri@nagoya-1st.jrc.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
札幌北楡病院（北海道）/ Sapporo Hokuyu Hospital（Hokkaido）
国立病院機構仙台医療センター（宮城県）/ Sendai Medical Center（Miyagi）
千葉ろうさい病院（千葉県）/ Chiba Rosai Hospital（Chiba）
順天堂大学医学部附属順天堂医院（東京都）/ Juntendo University Hospital（Tokyo）
海老名総合病院（神奈川県）/ Ebina General Hospital（Kanagawa）
日本赤十字社愛知医療センター名古屋第一病院 (愛知県)/ Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital (Aichi)
京都第二赤十字病院（京都府）/ Japanese Red Cross Society Kyoto Daini Hospital（Kyoto）
坂出市立病院（香川県）/ Sakaide City Hospital（Kagawa）
広島赤十字・原爆病院（広島県）/ Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital（Hiroshima）
佐賀県医療センター好生館（佐賀県）/ Saga Prefectural Hospital Koseikan（Saga）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
130
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
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 05 | Month | 08 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
Study Design:retrospective, observational, chart review study
Recruitment method :All patients meeting the inclusion criteria who attended a participating center between June 23, 2021 and September 30, 2022.
Data Component:Patient demographics, clinical characteristics, treatment information, and pathology report findings, as well as outcome data.
Management information
Registered date
| 2023 | Year | 02 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057222
