Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
ConditionPeripheral T-cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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).
Eligibility criteria
Qualifiers
Age range from 18 to 75 years;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Pathologically confirmed relapsed/refractory Peripheral T-cell lymphoma (Including PTCL-NOS, AITL, anaplastic large cell lymphoma（ALTL）, excluding Nature Killer（NK）/T cell lymphoma);
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);
Disqualifiers
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);
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;
Trial design
Treatments tested in this trial
- PD-1 antibody+ HDAC inhibitor
Treatment groups
51 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov