Adult T-cell Leukemia/Lymphoma (ATL)
Conditions
Interventions
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.
Sponsors
The study group for investigator-oriented clinical trial for the development of treatment of ATL.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate (best overall response) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactToshitaka Futagawa
Kagoshima University Hospital Clinical Research Management Center
Outcome results
None listed