UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020601
Receipt number R000023778
Scientific Title A phase II study of Nivolumab for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)
Date of disclosure of the study information 2016/01/17
Last modified on 2022/11/12 16:06:28

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Basic information

Public title

A phase II study of Nivolumab for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)

Acronym

A phase II study of Nivolumab for relapsed/refractory ATL

Scientific Title

A phase II study of Nivolumab for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)

Scientific Title:Acronym

A phase II study of Nivolumab for relapsed/refractory ATL

Region

Japan


Condition

Condition

Adult T-cell Leukemia/Lymphoma (ATL)

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To elucidate the efficacy and safety of Nivolumab for patients with relapsed or refractory aggressive ATL (acute, lymphoma, and chronic type with unfavorable prognostic factors) who had been treated by or intolerance/contraindication for mogamulizumab.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase II


Assessment

Primary outcomes

response rate (best overall response)

Key secondary outcomes

safety, response rate for relapsed ATL (best overall response), response rate for refractory ATL (best overall response), response rate according to disease sites (best overall response), progression free survival, overall survival, time to next treatment


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nivolumab will be administered at a dose of 3 mg per kilogram of body weight by intravenous infusion every 2 weeks until patients' condition meets discontinuance criteria.

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) Hematocytologically or pathohistologically proved peripheral lymphoid malignancy expressing T cell phenotype with positivity of anti-HTLV-1 antibody.

2) Relapsed or refractory ATL patients after one or more prior lines of chemotherapy under the diagnosis of aggressive ATL (acute type, lymphoma type, or chronic type with unfavorable factor).

3) Aged 20 or older

4) Performance status (ECOG) 0-2

5) Having at least one of measurable lesion, or evaluable lesion in either of peripheral blood or skin.

6) Fulfilling all of following for prior treatment
1. At least one regimen of cytotoxic chemotherapy and mogamulizumab, or at least one regimen of cytotoxic chemotherapy in case of intolerance/contraindication for mogamulizumab.
2. No history of treatment of immune checkpoint inhibitors (anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody).
3. More than 4 weeks of interval from the last chemotherapy to the scheduled first day of protocol treatment for ATL (excluding oral or external adrenocorticoids).
4. More than 4 weeks of interval from the last treatment by antibodies for ATL to the scheduled first day of protocol treatment
5. More than 4 weeks of interval from the last radiation for ATL to the scheduled first day of protocol treatment.
6. No history of treatment for other malignancies by chemotherapy and/or radiation.
7. No history of organ transplantation and/or allogenic hematopoietic stem cell transplantation.
8. More than 4 weeks of interval from the last administration of investigational drugs.

7) Adequate organ functions

8) Expected more than 3 months of survival

9) Written informed consent from the patient.

10) Women who can possibly become pregnant must agree to use birth control methods, and nursing women must agree to refrain it for 320 days from the last dose of the study drug.

11) Male must agree to the use of contraceptions for 320 days from the last dose of the study drug.

Key exclusion criteria

1) Synchronous or metachronous malignancy except carcinoma in situ or cancer confined to the mucosa and curatively treated by local resection.

2) Active infection requiring systemic treatment

3) Pregnant or nursing women

4) Psychological disturbance

5) Administration of systemic adrenocorticoids more than 10mg/day of predonisolone or equivalents except for the treatment of ATL, medical examination, or prophylactic use for allergic reaction, and/or immunosuppressants.

6) Diabetes mellitus poorly controlled and regularly treated by insulin.

7) Poorly controlled hypertension

8) Unstable angina and/or myocardial infarction within 6 months.

9) HBs-Ag positive or HBc-Ab positive with HBV-DNA positive.

10) HCV-Ab positive

11) HIV-Ab positive

12) Complication or history of interstitial pneumonia or pulmonary fibrosis diagnosed by image and/or symptoms

13) Complication or history of autoimmune diseases.

14) Suspicious findings of central nervous invasion.

15) Other inadequate conditions determined by investigators.

Target sample size

22


Research contact person

Name of lead principal investigator

1st name Ishitsuka
Middle name
Last name Kenji

Organization

Kagoshima University Hospital

Division name

Department of Hematology and Immunology

Zip code

890-8544

Address

8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan

TEL

099-275-5934

Email

kenji-i@m.kufm.kagoshima-u.ac.jp


Public contact

Name of contact person

1st name Toshitaka
Middle name
Last name Futagawa

Organization

Kagoshima University Hospital

Division name

Clinical Research Management Center

Zip code

890-8520

Address

8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan

TEL

099-275-5553

Homepage URL


Email

nivo-cc@m.kufm.kagoshima-u.ac.jp


Sponsor or person

Institute

The study group for investigator-oriented clinical trial for the development of treatment of ATL.

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD

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

Kagoshima University Hospital, Clinical Trial Review Board

Address

8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan

Tel

099-275-5553

Email

chiken@m3.kufm.kagoshima-u.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

鹿児島大学病院(鹿児島県)
国立病院機構熊本医療センター(熊本県)
名古屋市立大学病院(愛知県)
今村総合病院(鹿児島県)
福岡大学病院(福岡県)
熊本大学病院(熊本市)
九州大学病院(福岡市)


Other administrative information

Date of disclosure of the study information

2016 Year 01 Month 17 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

No longer recruiting

Date of protocol fixation

2015 Year 11 Month 30 Day

Date of IRB

2015 Year 12 Month 16 Day

Anticipated trial start date

2016 Year 01 Month 17 Day

Last follow-up date

2027 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 01 Month 17 Day

Last modified on

2022 Year 11 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023778


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name