Sintilimab (IBI308) in Combination With Chidamide and Azacitidine in Refractory or Relapsed PTCL

This is an interventional treatment trial for Peripheral T-cell Lymphoma Read More

Inclusion Criteria:

• Histopathologically confirmed PTCL;
• Disease status defined as relapsed or refractory after >=1 prior treatment lines;
• Prior use of HDACi or PD-1/PD-L1 antibodies or demethylation drugs is allowed;
• At least one measurable disease (defined as ≥ 1.5 cm in length-diameter, or 1.1~1.5 cm in length-diameter and >1.0 cm in short-diameter ) ；
• ECOG PS 0~2；
• Provide written informed consent for the trial；
• 18 ≤ age ≤ 80；
• Life expectancy ≥12 weeks;
• Adequate organ and bone marrow function, laboratory tests should be received within 7 days prior to the use of the research drug and meet the eligibility requirements;
• Subjects of reproductive potential must be willing to use adequate contraception during the course of the study and through 120 days after the last dose of study medication.

Exclusion Criteria:

• Known central nervous system lymphoma or cutaneous T-cell lymphoma;
• Received any immunesuppressive drugs within 4 weeks of the first dose of study medicationy, not including topical corticosteroids or systemic corticosteroids in physiological doses (≤10 mg/day prednisone or equivalent dose of other steroid);
• Patients with active autoimmune diseases requiring systematic treatment in the past two years;
• Received or plan to receive any attenuated vaccines within 4 weeks of the first dose of study medication;
• Received the last anti-tumor therapy within 4 weeks of the first dose of study medication or have not recovered (recovery defined as baseline or ≤ grade 1) from adverse events due to anti-cancer agents;
• Currently participating in an interventional clinical study, unless participating in observational study or during follow-up period of an interventional study;
• Received any investigational agent within 4 weeks of the first dose of study medication;
• Subjects with interstitial lung disease or lung disease that may interfere with the detection or treatment of suspected drug-related pulmonary toxicity;
• Other primary malignancy;
• Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation;
• Received autologous hemopoietic stem cell transplantation within 90 days of the first dose of study medication;
• Received major surgery or unhealed wound, ulcer or fracture within 4 weeks of the first dose of study medication;
• Active tuberculosis；
• Known primary immunodeficiency；
• Known allergy or hypersensitivity to any monoclonal antibodies or any components used in their preparation;
• Uncontrolled concomitant disease;
• Patients with active hepatitis. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA titer (no more than 50 IU/mL) and HCV RNA (no more than the lower limit of the detection method);
• History of gastrointestinal perforation and /or fistula within 6 months before enrollment;
• Hemophagocytic syndrome；
• Uncontrolled third space effusion, e.g. ascites or pleural effusion cannot be drained or controlled;
• Women who are pregnant or nursing；
• According to the researchers' judgment, patients' underlying condition may increase their risk of receiving research drug treatment, or confuse their judgment on toxic reactions;
• Other researchers consider it unsuitable for patients to participate in this study.