UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039968 |
|---|---|
| Receipt number | R000045562 |
| Scientific Title | An exploratory biomarker study in an investigator initiated phase II trial of atezolizumab in patients with relapsed/refractory NK/T-cell lymphoma |
| Date of disclosure of the study information | 2020/03/28 |
| Last modified on | 2024/03/30 11:47:15 |
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Basic information
Public title
A biomarker study for atezolizumab in patients with relapsed/refractory NK/T-cell lymphoma (ATTACK)
Acronym
A biomarker study for atezolizumab in patients with relapsed/refractory NK/T-cell lymphoma (ATTACK)
Scientific Title
An exploratory biomarker study in an investigator initiated phase II trial of atezolizumab in patients with relapsed/refractory NK/T-cell lymphoma
Scientific Title:Acronym
An exploratory biomarker study in an investigator initiated phase II trial of atezolizumab in patients with relapsed/refractory NK/T-cell lymphoma
Region
| Japan |
Condition
Condition
extranodal NK/T-cell lymphoma, nasal type (ENKL)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To explore the molecular biomarkers predicting efficacy of atezolizumab treatment for relapsed/refractory ENKL.
Basic objectives2
Others
Basic objectives -Others
Identification of biomarkers predicting therapeutic efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Gene alterations by targeted DNA sequence
2. Gene expression and fusion genes by targeted RNA sequence
3. Positive rate of PD-1, PD-L1, and PD-L2 by histopathological evaluation
Key secondary outcomes
1. Gene alterations and expressions by whole exome, whole genome, and RNA sequence
2. Gene expressions, TCR/BCR repertoires, surface markers, and antigen specificity by ingle cell analysis
3. Gene and surface marker expressions using preserved peripheral blood samples
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients enrolled in the NCCH1903 study who agree with the content of this biomarker study and submit the written consent form
Key exclusion criteria
None
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Kataoka |
Organization
National Cancer Center
Division name
Research Institute, Division of Molecular Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL
03-3542-2511
kekataok@ncc.go.jp
Public contact
Name of contact person
| 1st name | Junji |
| Middle name | |
| Last name | Koya |
Organization
National Cancer Center
Division name
Research Institute, Division of Molecular Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045
TEL
03-3542-2511
Homepage URL
jkoya@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1. Kyoto University Hospita
2. National Hospital Organization Nagoya Medical Center
3. Tohoku University Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Offices for research ethics, National Cancer Center
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.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
| 2020 | Year | 03 | Month | 28 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Related study:
NCCH1903, An investigator initiated phase II trial of Atezolizumab in patients with relapsed/refractory extranodal NK/T-cell lymphoma, nasal type
https://jrct.niph.go.jp/latest-detail/jRCT2031190177
Management information
Registered date
| 2020 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045562
