UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053363 |
|---|---|
| Receipt number | R000060909 |
| Scientific Title | A multicenter Retrospective Study of BV+CHP in Patients with Untreated CD30-Positive Adult T-cell Leukemia-Lymphoma |
| Date of disclosure of the study information | 2024/01/16 |
| Last modified on | 2024/09/30 22:03:29 |
* 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
A multicenter Retrospective Study of BV+CHP in Patients with Untreated CD30-Positive Adult T-cell Leukemia-Lymphoma
Acronym
A multicenter Retrospective Study of BV+CHP in Patients with Untreated CD30-Positive Adult T-cell Leukemia-Lymphoma
Scientific Title
A multicenter Retrospective Study of BV+CHP in Patients with Untreated CD30-Positive Adult T-cell Leukemia-Lymphoma
Scientific Title:Acronym
A multicenter Retrospective Study of BV+CHP in Patients with Untreated CD30-Positive Adult T-cell Leukemia-Lymphoma
Region
| Japan |
Condition
Condition
Adult T-cell leukemia/lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of BV for untreated CD30 positive adult T-cell/leukemia/lymphoma in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall Response Rate
Key secondary outcomes
Overall survival
Progression free survival
Complete response rate
Response rate by lesion site
Disease control rate
Time to treatment failure
Time to next treatment
Relative dose intensity
Safety (Adverse Events)
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 meet all of the following criteria are eligible for this study:
1. Patients aged 18 years or older at the time of informed consent or the time of Opt-out confirmed
2. Patient who have given informed consent (verbal consent to participate in this study during enrolment period. For patients who have difficulty giving oral consent or who have died at the time of study registration, the patient who does not refuse to participate the study via optout ) will be enrolled.
3. Patient who have been diagnosed untreated CD30 positive ATL and received brentuximab vedotin+CHP
Key exclusion criteria
Patients who meet the following criteria will be excluded from this study:
1.Patients considered ineligible for the study by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Soeda |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Oncology Business Unit
Zip code
103-8668
Address
2-1-1, Nihonbashi-Honcho Chuo-ku, Tokyo
TEL
03-3278-2111
japan.oncology.iir.office@takeda.com
Public contact
Name of contact person
| 1st name | Takara |
| Middle name | |
| Last name | Yamada |
Organization
Linical Co.,Ltd.
Division name
Contract Medical Affairs Unit, Clinical Trial Operations
Zip code
532-0003
Address
1-6-1 Miyahara,Yodogawa-ku,Osaka-shi,Osaka Prefecture
TEL
06-6150-2478
Homepage URL
yamada-takara@linical.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MINS Clinical Research Center, a non-profit organization
Address
2nd floor, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2024 | Year | 01 | Month | 16 | 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
46
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
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
ORR is the proportion of study subjects whose overall effect of antitumor efficacy criteria is CR, CRu and PR from the start of brentuximab vedotin regimen treatment to discontinuation or termination of administration. For the population to be analyzed for efficacy, ORR and 95% confidence intervals are calculated on both sides.
OS is calculated from the date of commencement of treatment of brentuximab vedotin regimen and to the date of death from any cause.
PFS is calculated from the date of commencement of treatment with brentuximab vedotin regimen until the date of determination of PD or the date of death from any cause, whichever comes first.
TTF is calculated from the date of commencement of treatment with brentuximab vedotin regimen until the date of decision to discontinue treatment, the date of exacerbation during treatment, or the date of death from any cause, whichever is earlier.
TTNT is calculated from the date of BV regimen start date to start date of next treatment.
RDI: Actual DI divided by standard DI
For OS, PFS, TTF and TTNT, the Kaplan-Meier method is used to calculate the median of the analysis items and the 95% confidence interval on both sides.
CR rate is the proportion of study subjects whose best overall effect is CR and CRu. Calculate the CR rate and its 95% confidence intervals on both sides. The response rate for each lesion site is also calculated.
DCR is the proportion of study subjects with the best overall effect CR, CRu. PR and SD. Calculate the DCR and the 95% confidence interval on both sides.
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060909
