UMIN-CTR Clinical Trial

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

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023778