Actively Recruiting
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
Led by Fudan University · Updated on 2026-04-02
51
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Pathologically confirmed relapsed or refractory peripheral T-cell lymphoma (excluding Natural Killer/T cell lymphoma)
- At least one measurable lesion with minimum size of 1.5 cm by 1.0 cm by CT or MRI
- Adequate blood cell counts (WBC ≥3.5×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥80×10⁹/L, HB ≥90 g/L) unless abnormal due to lymphoma involvement
- Adequate liver function (bilirubin, ALT, AST ≤1.5 times upper normal limit)
- Adequate kidney function (creatinine ≤1.5 times upper normal limit, clearance ≥50 ml/min)
- Heart function with left ventricular ejection fraction (LVEF) ≥50%
- Women of childbearing potential must use contraception and have negative pregnancy test within 2 weeks before enrollment
- Willingness to provide pathological tissue samples
- Expected survival time over 3 months
- Willingness to provide written informed consent
You will not qualify if you...
- Allergy to any drug in the study treatment
- Previous combined treatment with anti-PD-1 antibody and HDAC inhibitor (single-agent or sequential use allowed)
- Significant heart disease including NYHA class IV heart failure, unstable angina, recent myocardial infarction, congestive heart failure, or prolonged QTc interval
- Major surgery within 3 weeks before enrollment
- Other malignancy within 5 years except certain skin or cervical cancers treated curatively
- Antitumor therapy or clinical trial participation within 4 weeks before enrollment unless small-molecule drugs discontinued appropriately
- Significant blood clotting disorders
- Autoimmune diseases requiring systemic immunosuppressive treatment
- Serious uncontrolled diseases such as diabetes or lung disease
- Central nervous system disease
- Live vaccine received within 4 weeks before enrollment
- Active hepatitis B or C infection or other immune deficiency diseases including HIV
- Pregnancy or breastfeeding
- Previous organ transplant except autologous stem cell transplant
- Severe or uncontrolled infections
- History of severe neurological or psychiatric disorders
- Drug abuse or social/psychological conditions interfering with study
- Considered unsuitable for enrollment by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dongmei Ji
Shanghai, Shanghai Municipality, China, 021
Actively Recruiting
Research Team
D
Dongmei Ji, doctor
CONTACT
J
Junning Cao, doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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