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 2022/03/31 21:30:30

* 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 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

Email

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


Email

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

Email

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


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

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

2022 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045562


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name