relapsed or refractory cutaneous lymphoma
Conditions
Interventions
single arm:Sintilimab
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Cutaneous lymphoma confirmed by histopathology. 2. Relapsed or refractory malignant lymphoma that has failed in second-line or above treatment (including radiotherapy or autologous hematopoietic stem cell transplantation). Subjects who did not achieve remission or progress after autologous hematopoietic stem cell transplantation can be included in the group. 3. There should be at least one measurable focus (the long diameter of the focus is more than 15 mm or the long diameter of the focus is 11 mm ~ 15 mm but the short diameter is more than 10 mm, and the focus has uptake on the 18FDG-PET scan). 4. ECoG PS score is 0-2. 5. Sign the written informed consent and be able to follow the visit and relevant procedures specified in the plan. 6. Aged >= 18 years. 7. Expected survival time >= 12 weeks. 8. The female subjects of childbearing age or the male subjects whose sexual partners are women of childbearing age should take effective contraceptive measures in the whole treatment period and within 90 days after the last treatment 9. It has sufficient organ and marrow functions, which are defined as follows: Blood routine test: ANC >= 0.75 x 10^9 / L, PLT >= 50 x 10^9 / L, Hgb >= 8.0 g / dl; no granulocyte growth factor, platelet transfusion or red blood cell transfusion was received within 14 days before the test. Liver function: TBIL <= 1.5 x ULN; ALT and AST <= 2.5 x ULN. Renal function: Cr <= 1.5 × ULN. Thyroid function: TSH is within the normal range (Note: TSH abnormalities caused by non autoimmune reasons can be included in the group).
Exclusion criteria
Exclusion criteria: 1. It is known that nodular lymphocytes are the main type of cutaneous malignant lymphoma. 2. Central nervous system lymphoma. 3. We received hematopoietic stem cell transplantation 90 days before the first dose of study. 4. Previously exposed to any anti-PD-1, anti-PD-L1 or anti-CTLA-4 antibody. 5. Participate in another intervention clinical study at the same time, unless participating in the observation (non intervention) clinical study or in the follow-up stage of the intervention study. 6. Received any investigational drug within 4 weeks before the first dose of study treatment. 7. Receive the last radiotherapy or anti-tumor treatment (chemotherapy, targeted treatment, immunotherapy or tumor embolization, etc.) within 3 weeks before the first dose of study treatment; receive the last nitrosourea or mitomycin C treatment within 6 weeks before the first dose of study treatment. 8. Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding local or physiological doses of systemic glucocorticoids (i.e. no more than 10 mg / day of prednisone or other equivalent doses of glucocorticoids) by nasal spray, inhalation or other routes. 9. Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period. 10. Major surgery (craniotomy, thoracotomy or laparotomy) or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose of study treatment. 11. Active, known or suspected autoimmune diseases (refer to Annex 6) or the history of the disease in the past 2 years (in recent years). Patients with vitiligo, psoriasis, alopecia or Graves' disease who do not need systematic treatment within 2 years, hypothyroidism who only need thyroid hormone replacement treatment and type I diabetes who only need insulin replacement treatment can be included in the group. 12. Known history of primary immunodeficiency. 13. Active tuberculosis is known. 14. We have known the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation. 15. Known allergy to any monoclonal antibody. 16. Uncontrolled concurrent diseases include but are not limited to: People infected with HIV (HIV antibody positive). Serious infection in active period or poor clinical control. Symptomatic congestive heart failure (New York Heart Association class III-IV) or symptomatic or poorly controlled arrhythmia. Uncontrolled arterial hypertension (systolic pressure >= 160mmhg or diastolic pressure) even after standard treatment >= 100mmHg) Any event of arterial thromboembolism, including myocardial infarction, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, occurred within 6 months before the treatment. Any life-threatening bleeding event or grade 3 or 4 gastrointestinal / variceal bleeding event requiring blood transfusion, endoscopic or surgical treatment occurred within 3 months prior to inclusion in the study. There was a history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before the group was enrolled (implantable vein transfusion port or catheter-based thrombosis, or superficial vein thrombosis is not considered as serious thromboembolism). Uncontrolled metabolic disorder or other secondary reactions of non malignant tumor organs or systemic diseases or cancer, which may lead to higher medical risk and / or uncertainty of survival evaluat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Countries
China
Contacts
Public ContactQing Xu
Shanghai Tenth People's Hospital
Outcome results
None listed