UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051410 |
|---|---|
| Receipt number | R000058571 |
| Scientific Title | Darinaparsin-T cell lymphoma-Study |
| Date of disclosure of the study information | 2023/06/22 |
| Last modified on | 2023/12/22 09:17:52 |
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Basic information
Public title
Darinaparsin-T cell lymphoma-Study
Acronym
DARTS Study
Scientific Title
Darinaparsin-T cell lymphoma-Study
Scientific Title:Acronym
Darinaparsin-T cell lymphoma-Study
Region
| Japan |
Condition
Condition
Peripheral T-cell lymphoma
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability of Darinaparsin in clinical environment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of treatment discontinuation due to adverse events other than vascular pain by the completion of three treatment cycles.
Key secondary outcomes
(1)Percentage of patients who shifted from peripheral vascular administration to central venous administration due to vascular pain when administered via peripheral vessels
(2)Numerical rating scale (NRS) for vascular pain when administered via peripheral vessels
(3)Correlation between metabolic tumor volume* (PET scan) and response rate
(4)overall response rate:ORR
(5)complete response rate:CRR
(6)disease control rate:DCR
(7)progression-free survival:PFS
(8)overall survival:OS
(9)duration of response:DOR
(10)time to response:TTR
(11)Response rate by histological type, various survival indices(PFS, OS, DOR)
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) Cases with pathologic diagnosis of peripheral T-cell lymphoma by tissue biopsy. If possible, the diagnosis should be made on a post-relapse biopsy; however, if the relapse occurred at a site that is difficult to biopsy, the pathologic diagnosis at the time of initial disease is acceptable. The following pathologic types according to the WHO classification of Tumors of Hematopoietic and Lymphoid Tissues 2017 edition are included.
PTCL, NOS
AITL
Follicular T-cell lymphoma
Nodal peripheral T-cell lymphoma with T follicular helper phenotype
ALK+ ALCL
ALK- ALCL
2) Patients with relapsed/refractory disease who have received at least one regimen of prior therapy after diagnosis. (Do not include patients treated with radiation alone or steroids alone.)
3) Patients must be at least 20 years old at the time of consent.
4) Eastern Cooperative Oncology Group (ECOG)-performance status (PS) of 0 to 3 at the time of enrollment.
5) Cases with more than one evaluable lesion (measurable in two orthogonal directions on CT and with a maximum tumor diameter of 1.5 cm or greater)
6) Written consent for participation in this study is obtained from the patient.
Key exclusion criteria
1) Patients with QT prolongation on 12-lead ECG (for QT prolongation, QT > 450 msec for males and QT > 470 msec for females; the Fridericia correction formula: QTc=(QT interval)/(RR interval)1/3 should be used to calculate the QT interval).
2) Complicated severe infection.
3) Pregnant or possibly pregnant women.
4) Patients with psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
5) Patients with active multiple cancers (including synchronous multiple cancers, multiple cancers, and iatrogenic multiple cancers with a disease-free interval of less than 5 years. However, even if the disease-free period is less than 5 years, stage I prostate cancer and the following carcinomas that have been completely resected shall not be included in active overlapping or multiple cancers. Gastric cancer (adenocarcinoma): stage 0-I; Colon cancer (adenocarcinoma): stage 0-I; Rectal cancer (adenocarcinoma): stage 0-I; Esophageal cancer (squamous cell carcinoma, adenosquamous carcinoma, basal cell carcinoma): stage 0; Breast cancer (noninvasive ductal carcinoma of breast, noninvasive lobular carcinoma): stage 0; Breast cancer (invasive ductal carcinoma of breast, invasive lobular carcinoma, Paget's disease): stage 0-IIA; Uterine cancer (endometrial adenocarcinoma Stage I), Prostate cancer (adenocarcinoma): Stage I-II, Cervical cancer (squamous cell carcinoma): Stage 0, Thyroid cancer (papillary carcinoma, follicular carcinoma): Stage I-III, Renal cell carcinoma (light-displicated renal cell carcinoma, anaplastic renal cell carcinoma): Stage I)
6) Patients with known hypersensitivity to any component of darinaparsin and those who have received darinaparsin in the past.
7) Cases in which the principal investigator or research coordinator determines that the patient is not appropriate to participate in this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamauchi |
Organization
University of Fukui Hospital
Division name
Department of Hematology and Oncology
Zip code
910-1193
Address
23-3 Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-3111
tyamauch@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Eiju |
| Middle name | |
| Last name | Negoro |
Organization
University of Fukui Hospital
Division name
Department of Hematology and Oncology
Zip code
910-1193
Address
23-3 Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL
0776-61-3111
Homepage URL
enegoro@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Nippon Kayaku Co.,Ltd
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
University of Fukui IRB
Address
23-3 Matsuoka-shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel
0776-61-8529
chiken@ml.u-fukui.ac.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 | 06 | Month | 22 | 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 | 06 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multicenter, non-interventional, observational study
Management information
Registered date
| 2023 | Year | 06 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058571
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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