UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057043 |
|---|---|
| Receipt number | R000065087 |
| Scientific Title | Predictive and early prognostic biomarkers of valemetostat for adult T-cell leukemia-lymphoma |
| Date of disclosure of the study information | 2025/03/03 |
| Last modified on | 2025/02/06 18:53:46 |
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Basic information
Public title
Predictive and early prognostic biomarkers of valemetostat for adult T-cell leukemia-lymphoma
Acronym
BIVA study
Scientific Title
Predictive and early prognostic biomarkers of valemetostat for adult T-cell leukemia-lymphoma
Scientific Title:Acronym
BIVA study
Region
| Japan |
Condition
Condition
Adult T-cell leukemia-lymphoma (ATL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Identification of predictive and early prognostic peripheral blood biomarkers for valemetostat in patients with ATL in real-world settings
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage change in H3K27me3-Flow methylated histone levels pre- and post-valemetostat administration
Key secondary outcomes
1-year progression-free survival
1-year overall survival
1-year event-free survival
Overall response rate
Complete response rate
Adverse events
Alterations in whole-exome sequencing and gene expression analysis pre- and post- valemetostat administration
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients registered in the aggressive ATL registry
2) Patients with relapsed or refractory ATL for whom therapeutic options have been adequately explained, and who are scheduled for initial administration of valemetostat
3) Patients aged 16 years or older
4) Written informed consent for participation in this study has been obtained from the patient. However, if the patient is between 16 and 18 years of age at the time of registration, written informed consent must be obtained both from the patient and from an adult guardian (or legally authorized representative)
Key exclusion criteria
1) Patients with a history of valemetostat administration (including administration in clinical trials) prior to enrollment in this study
2) Patients with a history of allogeneic hematopoietic stem cell transplantation. However, patients scheduled for transplantation are eligible for enrollment.
3) Patients who plan or are expected to relocate or receive follow-up care outside the study institution within two weeks after valemetostat administration
4) Patients who are pregnant or potentially pregnant women, or women who are breastfeeding
5) Patients who are considered to be unsuitable for enrollment by the physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Kusumoto |
Organization
Aichi Cancer Center Hospital
Division name
Department of Hematology and Cell Therapy
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
TEL
052-762-6111
skusumot@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Makiyama |
Organization
Sasebo City General Hospital
Division name
Department of Hematology
Zip code
857-8511
Address
9-3 Hirase-cho, Sasebo, Nagasaki, Japan
TEL
0956-24-1515
Homepage URL
jmakiyama@hospital.sasebo.nagasaki.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Shigeru Kusumoto
Funding Source
Organization
Daiichi Sankyo Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japan Agency for Medical Research and Development (AMED)
IRB Contact (For public release)
Organization
Aichi Cancer Center Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, Japan
Tel
052-762-6111
irb@aichi-cc.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
北海道大学病院（北海道）、札幌北楡病院（北海道）、岩手医科大学附属病院（岩手県）、山形大学医学部附属病院（山形県）、埼玉医科大学国際医療センター（埼玉県）、地方独立行政法人総合病院国保旭中央病院 血液内科（千葉県）、国立がん研究センター東病院（千葉県）、国立がん研究センター中央病院（東京都）、東京大学医科学研究所附属病院（東京都）、東京大学（東京都）、東京科学大学病院（東京都）、東京慈恵会医科大学（東京都）、公益財団法人がん研究会有明病院（東京都）、神奈川県立がんセンター（神奈川県）、聖マリアンナ医科大学病院（神奈川県）、岐阜大学医学部附属病院（岐阜県）、愛知県がんセンター（愛知県）、名古屋市立大学病院（愛知県）、愛知医科大学（愛知県）、愛知県厚生農業協同組合連合会 豊田厚生病院（愛知県）、滋賀医科大学医学部附属病院（滋賀県）、京都大学医学部附属病院（京都府）、日本赤十字社京都第一赤十字病院（京都府）、日本赤十字社京都第二赤十字病院（京都府）、関西医科大学附属病院（大阪府）、パナソニック健康保険組合 松下記念病院（大阪府）、JR大阪鉄道病院（大阪府）、大阪国際がんセンター（大阪府）、近畿大学医学部（大阪府）、神戸大学医学部附属病院（兵庫県）、兵庫県立尼崎総合医療センター（兵庫県）、近畿大学奈良病院（奈良県）、和歌山県立医科大学附属病院（和歌山県）、紀南病院（和歌山県）、鳥取大学医学部附属病院（鳥取県）、島根大学医学部附属病院（島根県）、広島赤十字・原爆病院（広島県）、久留米大学病院（福岡県）、九州大学病院（福岡県）、国立病院機構九州がんセンター（福岡県）、九州医療センター（福岡県）、福岡大学病院（福岡県）、佐賀県医療センター好生館（佐賀県）、唐津赤十字病院（佐賀県）、長崎大学病院（長崎県）、国立病院機構長崎医療センター（長崎県）、地域医療機能推進機構諫早総合病院（長崎県）、佐世保市総合医療センター（長崎県）、熊本大学病院（熊本県）、くまもと森都総合病院（熊本県）、国立病院機構熊本医療センター（熊本県）、JCHO熊本総合病院（熊本県）、大分県立病院（大分県）、大分大学医学部附属病院（大分県）、宮崎大学医学部附属病院（宮崎県）、県立宮﨑病院（宮崎県）、公益財団法人 慈愛会 今村総合病院（鹿児島県）、鹿児島大学病院（鹿児島県）、国立病院機構鹿児島医療センター（鹿児島県）、青仁会池田病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 03 | 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
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to integrate pre- and post-treatment data-including methylated histone levels, genomic abnormalities, gene expression profiles, and clinical information-to identify candidate biomarkers that predict the therapeutic efficacy of valemetostat.
Management information
Registered date
| 2025 | Year | 02 | Month | 16 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065087
