Sintilimab Combined With Chidamide in Treating Peripheral T Cell Lymphoma

NCT04512534 | Recruiting Phase 2

• 1 other identifier: Sincerely2020
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Peripheral T-cell Lymphoma

Keywords

relapsed/refractory peripheral T-cell lymphoma; PD-1 antibody; HDAC inhibitor; objective response rate; safety profile

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  Time from the data of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.

  Up to two years after the start of the study

Secondary Outcomes (2)

• Overall Survival (OS)

  Up to two years after the start of the study

• incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Since the signing of informed consent forms to 30 days after the last cycle of treatment and 90 days after last dose of anti-PD-1 antibody

Other Outcomes (1)

• biomarker

  the collection of the samples will begin from the signing of informed consent forms（ICF）, and the detection will be competed within 3 months after the last patient discontinued the treatment

Study Arms (1)

Sinitilimab+Chidamide

EXPERIMENTAL

Anti-PD-1 antibody Sintilimab 200mg intravenously every 3 weeks; HDAC inhibitor Chidamide 30mg orally twice every week

Drug: PD-1 antibody+ HDAC inhibitor

Interventions

PD-1 antibody+ HDAC inhibitor DRUG

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.

Also known as: Sintilimab, Chidamide

Sinitilimab+Chidamide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• 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%;
• Patients of child-bearing period agree to use appropriate contraception. The serum pregnancy test of women in childbearing period was negative within 2 weeks before enrollment.
• Willingness to provide pathological tissue specimens (20 pieces of wax or paraffin tissue sections);
• Expectation survival time over 3 months;
• Willingness to provide written informed consent.

You may not qualify if:

• 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;
• 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;
• Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interfere with results interpretation, including uncontrolled diabetes, or pulmonary disease (a history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm);
• Evidence of central nervous system disease;
• Patients who received the live vaccine within 4 weeks of the start of the enrollment;
• Patients with hepatitis B (HBV HBsAg positive and HBV-DNA≥105), hepatitis C (HCV) infection (HCV antibody positive and HCV-RNA detectable); And subjects with other acquired or congenital immune deficiency diseases, including but not limited to hiv-infected;
• Pregnant or lactating women;
• Patients who have had previous organ transplants (except autologous hematopoietic stem cell transplants);
• Severe or uncontrolled infections;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Dongmei Ji

Shanghai, Shanghai Municipality, 021, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

sintilimab; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Dongmei Ji, doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

• Junning Cao, Doctor

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Ji, doctor

CONTACT

13564183928; jidongmei2000@126.com

Junning Cao, doctor

CONTACT

cao_junning@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Simon's optimal two-stage design

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 13, 2020
• Study Start: November 13, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)