UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050967 |
|---|---|
| Receipt number | R000058065 |
| Scientific Title | The frequency of uMRD in Japanese patients with CLL after 24 months of treatment with Venetoclax plus/minus Rituximab in the 2L+ in the real-world setting |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2023/12/06 19:20:46 |
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Basic information
Public title
The frequency of uMRD in Japanese patients with CLL after 24 months of treatment with Venetoclax plus/minus Rituximab in the 2L+ in the real-world setting
Acronym
Japan CLL-MRD study
Scientific Title
The frequency of uMRD in Japanese patients with CLL after 24 months of treatment with Venetoclax plus/minus Rituximab in the 2L+ in the real-world setting
Scientific Title:Acronym
Japan CLL-MRD study
Region
| Japan |
Condition
Condition
Chronic Lymphocytic Leukemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe the frequency of uMRD (undetectable Minimal/Measurable Residual Disease) at 24 months (+3 months) after treatment with Venetoclax plus/minus Rituximab in the 2L+ in the real-world setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of uMRD at 24 months (+3 months) of treatment with Venetoclax plus/minus Rituximab
Key secondary outcomes
The frequency of L-MRD (Low-Minimal/Measurable Residual Disease) at 24 months (+3 months) of treatment with Venetoclax plus/minus Rituximab
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. Adult (18 years old or more) patients diagnosed with relapsed/refractory (2L+) CLL in Japan based on iwCLL criteria at the time of informed concent
2. Patients during treatment with Venetoclax plus/minus Rituximab for 24 months who are not treated with any other concurrent CLL treatment
3. Patients who are expected to visit the hospital at + 3 months after treatment with Venetoclax plus/minus Rituximab for 24 months
4. Patients who give informed consent (or by her/his guardian) for participating this study
Key exclusion criteria
1. Patients with no data on information on the start and end dates or continuation of treatment with Venetocalx
2. Patients participating in other clinical trials
Target sample size
89
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Taniai |
Organization
AbbVie GK
Division name
Medical Affairs
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo 108-0023, Japan
TEL
03-4577-1111
hisashi.taniai@abbvie.com
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Takenaka |
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
risa.takenaka@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
National Hospital Organization Nagoya Medical Center
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi 460-0001, Japan
Tel
052-951-1111
311-rec@mail.hosp.go.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
| 2023 | Year | 05 | Month | 08 | 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
| 2023 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A multicenter, cross-sectional study
Population: Japanese patients with CLL after 24 months of treatment with Venetoclax plus/minus Rituximab in the 2L+ in the real-world setting
Variables: Patient characteristics, comobidities, treatment patterns, clinical outcoms and MRD
Management information
Registered date
| 2023 | Year | 05 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058065
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| Registered date | File name |
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| Registered date | File name |
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