RecruitingPhase 2NCT04512534

Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma

A Phase II Study of Anti-Programmed Death-1(PD-1) Antibody Sintilimab Plus Histone Deacetylase(HDAC) Inhibitor Chidamide in Patients With Relapsed/ Refractory Peripheral T-cell Lymphoma

Sponsor

Fudan University

Enrollment

51 participants

Start Date

Nov 13, 2020

Study Type

INTERVENTIONAL

Conditions

Peripheral T Cell Lymphoma

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of sintilimab (an immunotherapy drug) and chidamide (a drug that reprograms cancer cell gene expression) for peripheral T-cell lymphoma — a group of rare, aggressive blood cancers — that has come back or is not responding to treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with relapsed or refractory peripheral T-cell lymphoma (specific subtypes: PTCL-NOS, AITL, or anaplastic large cell lymphoma) - You have at least one measurable tumor on imaging - You are in adequate overall health (ECOG performance status 0–2) **You may NOT be eligible if...** - You have NK/T-cell lymphoma (a related but different subtype) - You have uncontrolled infections, including active hepatitis or HIV - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPD-1 antibody+ HDAC inhibitor

Patients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows: * Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission（CR）patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles. * Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator.