malignant lymphoma, myelodysplastic syndromes
Conditions
Interventions
Nivolumab (240mg/day) is injected intravenously at Day 1. (One cycle is 14 days).
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with written informed consent. 2) Be >=20 years of age on the day of signing the informed consent. 3) Patients with Follicular lymphoma or Diffuse large B-cell lymphoma or Extranodal NK/T-cell lymphoma nasal type or myelodysplastic syndrome. patients has been confirmed histologically or cytologically. 4) Recurrent or relapsed after the last chemotherapy is completed or refractory or intolerance to the most recent chemotherapy. MDS patients resistant or intolerant to azacitidine. 5) Have an ECOG performance status of 0 or 1. 6) Have one or more evaluable lesions -Lymphoma: A CT image or MRI image with a lesion whose major axis exceeds 15 mm (a lesion with a minor axis exceeding 10 mm when the major axis is 11 mm or more and 15 mm or less) has clearly measurable lesions in two orthogonal directions -MDS: Bone marrow aspiration is possible and the proportion of blasts in bone marrow can be assessed 7) Demonstrated adequate organ function. 8) Female subjects of childbearing potential have a negative urine or serum pregnancy test within 7 days prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 9)Women of childbearing potential agree to use double contraception methods from day of the informed consent through at least after 5 months of final administration. Women agree to not to breast-feed from day of the informed consent through at least after 5 months of final administration. Men agree to take double contraception from day of first dose through at least after 7 months of final administration.
Exclusion criteria
Exclusion criteria: 1) Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy within 2weeks prior to enrollment Received immunotherapy within 28 days prior to enrollment. 2) Patients with therapeutic history of immune checkpoint inhibitor 3) Patients with hypertension that is difficult to control despite taking multiple medications 4) Patients with a history or finding of congestive heart failure of NYHA classification III or higher 5) Patients with acute coronary syndrome, coronary angioplasty, or stent placement, within 6 months prior to enrollment. 6) Patients with grade 3 or higher active infections according to CTCAE v 4.0 7) Patients with complication or previous history of interstitial lung disease with active symptoms or signs 8) Patients with autoimmune disease complications or a history of chronic / recurrent autoimmune disease 9) Patients requiring systemic adrenocortical hormone or an immunosuppressant, or patients received these treatments within 14 days prior to enrollment. 10) Have type I diabetes, or have type II diabetes mellitus which cannot be adequately controlled by insulin therapy 11) Have history of organ transplantation or allogeneic hematopoietic stem cell transplantation. 12) Patients with seizure disorder requiring drug treatment 13) Grade 3 or more bleeding was confirmed 4 weeks before enrollment 14) Patients with double cancer 15) Major surgery within 2 weeks 16)Patients with wounds, ulcers, or fractures that have not healed 17) Either HIV antibody, HBs antigen or HCV antibody test is positive. 18) Patients with a history of hypersensitivity to investigational drugs, similar drugs or excipients 19) Pregnant women, lactating women or possibly pregnant women 20) Patients judged unsuitable to evaluation of Nivolumab or interpretation of the result
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Confirmed objective response rate;ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;PFS Overall survival;OS Duration of response;DoR time to response Rate of Adverse Event | — |
Countries
Japan
Contacts
Public ContactYosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse Yosuke Minami, Nobuhiko Yamauchi, Nozomu Fuse
National Cancer Center Hospital East Department of Hematology
Outcome results
None listed