Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma (NCT04512534) | Clinical Trial Compass
RecruitingPhase 2
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
China51 participantsStarted 2020-11-13
Plain-language summary
This is a single-center, single-arm, phase 2 study to evaluate the efficacy and safety of Anti-PD-1 antibody(Sintilimab) plus HDAC inhibitor(Chidamide) in patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age range from 18 to 75 years;
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
✓. At least one two-dimensional measurable lesion with a length diameter of at least 1.5cm and vertical diameter of at least 1.0cm (measured by CT or MRI);
✓. Adequate medullary hematopoiesis function ( WBC≥3.5×109/L, ANC≥1.5×109/L, PLT≥80×109/L, HB≥90g/L. If the peripheral blood indicators demonstrate abnormal due to bone marrow or spleen invasion by lymphoma, Enrollment decision can be determined by the investigator as appropriate;
✓. Adequate hepatic function (total serum bilirubin, ALT and AST≤1.5 times of upper limit of normal);
✓. Adequate renal function (serum creatinine≤1.5 times the upper limit of normal, creatinine clearence≥50ml/min);
✓. Echocardiography or radionuclide cardia functional test, LVEF≥50%;
Exclusion criteria
✕. Patients allergic of any drug in this regimen;
✕. Previous treatment with anti-PD-1 antibody combined with HDAC inhibitor (Patients only received single agent of treatment regime or sequentially received anti-PD-1 and HDAC inhibitor are allowed to enroll);
✕
What they're measuring
1
Progression Free Survival (PFS)
Timeframe: Up to two years after the start of the study
. Patients with clinically significant heart disease, including severe cardiac insufficiency: New York Heart Disease Association (NYHA) grade IV cardiac insufficiency, unstable angina. And myocardial infarction, congestive heart failure, and QTC interphase \> 500ms which occurred before 6 month of screening;
✕. Patients who have received grade II or above surgery within 3 weeks before enrollment;
✕. History of other malignancy within the past 5 years (except for 1. basal cell carcinoma of the skin and 2. carcinoma in situ of the cervix and 3. patients who had received treatment for the purpose of cure and had not developed a malignant tumor with a known active disease in the previous 5 years);
✕. Patients who had received other antitumor therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks before the start of the enrollment (if patients received small-molecule targeted drug therapy, they could be included in the study if the drug was discontinued for more than 5 half-lives), or had not recovered from the previous toxicity;
✕. Patients with significant coagulation abnormality;
✕. Patients with autoimmune diseases requiring treatment or with a history of syndrome requiring systemic use of steroid immunosuppressive agents, such as hypophysitis, pneumonia, colitis, hepatitis, nephritis, hyperthyroidism, hypothyroidism, etc;