A phase II study of Nivolumab for relapsed/refractory adult T-cell leukemia/lymphoma (ATL)
- Conditions
- Adult T-cell Leukemia/Lymphoma (ATL)
- Registration Number
- JPRN-UMIN000020601
- Lead Sponsor
- The study group for investigator-oriented clinical trial for the development of treatment of ATL.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 22
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate (best overall response)
- Secondary Outcome Measures
Name Time Method 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