peripheral T-cell lymphoma
Conditions
Interventions
experimental group:Sintilimab+IBI376
Sponsors
Jiangsu Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed PTCL, including but are not limited to PTCL-NOS, AITL, ALK-ALCL and ENKTL; 2. Relapsed or refractory PTCL, patients who do not response or patients with relapsed disease or PD after autologous stem cell transplantation; 3. The presence of an assessable lesion was defined as a lesion length >= 15mm and vertical diameter >= 10mm, or uptake of the lesion on an 18 FDG-PET scan; 4. Eastern Cooperative Oncology Group Performance Status scores of 0-2; 5. Signed the inform consent form and able to comply with the scheduled follow-up visits and related procedures required in the protocol; 6. Aged from 18 to 70 years; 7. Life expectancy >= 12 weeks; 8. Patients (female patients at childbearing age or male patients whose partners are at childbearing age) must take effective contraceptive measures during the entire course of the trial and within 90 days since the last dose of treatment; 9. Adequate organs and bone marrow functions, as defined below: (1) Count of whole blood cells: absolute neutrophil count >= 1.0x10^9/L, platelets count >= 50x10^9/L, hemoglobin >= 8.0g/L, granulocyte colony-stimulating factor, PLT, or red blood cell transfusion has not been performed within 7 days prior to the test. (2) Hepatic function: total bilirubin <= 1.5 ULN, alanine aminotransferase and aspartate aminotransferase <= 2.5 ULN; (3) Renal function:serum creatinine <= 1.5 ULN; (4) Thyroid function: normal thyroid stimulating hormone (TSH) at baseline, or abnormal TSH at baseline with normal thiiodothronine (T3)/thiiodothronine (T4) and no symptoms.
Exclusion criteria
Exclusion criteria: 1. Patients with primary or secondary central nervous system (CNS) lymphoma; 2. Patients with severe hemophagocytic syndrome at initial diagnosis; 3. Patients with pulmonary great vessel invasion; 4. Previous exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 or PI3K inhibitors; 5. Enrolled in another interventional clinical study, unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study; 6. Received any investigational drug within 4 weeks prior to the first dose of study treatment; 7. The last dose of radiation or anti-tumor therapy (chemotherapy, targeted therapy or tumor embolization) was within 3 weeks prior to receiving the first dose of study treatment; the last dose of nitrosourea or mitomycin C treatment was within 6 weeks prior to receiving the first dose of study treatment; 8. Received immunosuppressants within 4 weeks prior to the first dose of study treatment, excluding local glucocorticoids administered by nasal, inhaled, or other topical routes, or systemic glucocorticoids of physiological doses (no more than 10 mg/day of prednisone or equivalents); 9. Received any live attenuated vaccine within 4 weeks prior to the first dose of study treatment, or is scheduled to receive live attenuated vaccine during the study period; 10. Received major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks prior to the first dose of study treatment, or has unhealed wounds, ulcers, or fractures; 11. Active, known, or suspected autoimmune disease or previous medical history of these diseases within 2 years (patients with vitiligo, psoriasis, alopecia, or Graves' disease not requiring systemic treatment, hypothyroidism only requiring thyroid replacement, or type I diabetes only requiring insulin can enroll); 12. Known history of primary immunodeficiency diseases; 13. Known active pulmonary tuberculosis; 14. Known history of allogeneic organ transplantation or allogeneic hem atopoietic stem cell transplantation; 15. Known to be allergic to any ingredients of monoclonal antibodies; 16. Uncontrolled concurrent diseases including but not limited to: (1) HIV-infected patients (positive anti-HIV antibody); (2) Active or poorly controlled severe infections; (3) Symptomatic congestive heart failure (NYHA Class III-IV) or symptomatic or poorly controlled arrhythmia; (4) Uncontrolled hypertension (systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg) despite of standard treatment; (5) Any arterial thromboembolic events occurred within 6 months prior to enrollment, including myocardial infarction, unstable angina, cerebrovascular accident, or transient cerebral ischemic attack; (6) Life-threatening hemorrhagic events or grade 3-4 gastrointestinal/variceal hemorrhage requiring blood transfusion, endoscopy, or surgical treatment within 3 months prior to enrollment; (7) History of deep venous thrombosis, pulmonary embolism, or other serious thromboembolic events within 3 months prior to enrollment (implantable port or catheter-related thrombosis, or superficial venous thrombosis are not considered as serious thromboembolisms); (8) Uncontrolled metabolic disorders, non-malignant organ or systemic diseases, or cancer-related secondary diseases that may lead to higher medical risks and/or survival evaluation uncertainties; (9) Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh grade B or C; (10) Bowel obstruction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective respond rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Overall survival;Complete respond rate;Partial respond rate;Desease control rate;Time to repond;Duration of respond; | — |
Countries
China
Contacts
Public ContactFan Lei
Jiangsu Province Hospital
Outcome results
None listed