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

Who is this study for? Patients with relapsed/refractory peripheral T-cell lymphoma
What treatments are being studied? PD-1 antibody+HDAC inhibitor
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Dongmei Ji
RECRUITING
Shanghai
Contact Information
Primary
Dongmei Ji, doctor
jidongmei2000@126.com
13564183928
Backup
Junning Cao, doctor
cao_junning@126.com
Time Frame
Start Date: 2020-11-13
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 51
Treatments
Experimental: Sinitilimab+Chidamide
Anti-PD-1 antibody Sintilimab 200mg intravenously every 3 weeks; HDAC inhibitor Chidamide 30mg orally twice every week
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov