PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma

Study Overview
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Brief Summary
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To observe the safety, tolerability and clinical effects of PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Detailed Description
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Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. The investigators have been proceeding this trial to evaluate the efficacy and safety of the PD-1, chidamide, lenalidomide and gemcitabine in the treatment of newly diagnosed and relapse/refractory peripheral T-cell lymphoma.

Official Title
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Single-arm, Multi-center Clinical Study of PD-1 Antibody, Chidamide, Lenalidomide and Gemcitabine for Peripheral T-cell Lymphoma

Conditions
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Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age:14-65 years;Eastern Cooperative Oncology Group (ECOG)score≤3;expected survival≥3 months patients with Peripheral T-cell Lymphoma diagnosed by immuno-histochemistry (IHC); acceptable hematological indicators, no chemotherapy contraindications; total bilirubin ≤ 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x upper age limit (ULN), if the abnormal laboratory parameters are considered to be caused by lymphoma, patients Eligible conditions should be adjusted to be incorporated into the group; At least one measurable lesion by CT or PET-CT（Positron Emission Tomography-Computed Tomography）; exclude other major diseases, normal heart and lung function; Female patients of childbearing age are negative for pregnancy test; Cooperate with follow-up; There are no other related treatments including traditional Chinese medicine, immunotherapy, and biologic therapy (except for the treatment of anti-bone metastases and other symptoms); Signing informed consent *: Pathological histology must be consulted by a pathologist at a provincial hospital. Exclusion Criteria: Patients with ALK-positive Anaplastic Large Cell Lymphoma or angioimmunoblastic T-cell lymphoma rejecting providing blood preparation; allergic to drug in this study and with metabolic block; rejecting adopting reliable contraceptive method in pregnancy or lactation period; uncontrolled internal medicine disease(including uncontrolled diabetes,severe incompetence cardiac, lung, liver and pancreas）； with severe infection; with primary or secondary central nervous system tumor invasion; with immunotherapy or radiotherapy contraindication; ever suffered with malignant tumor; having peripheral nervous system disorder or dysphrenia; with no legal capacity,medical or ethical reasons affecting research proceeding; participating other clinical trials simultaneously; adopting other anti-tumor medicine excluding this research; Patients with immunodeficiency, such as primary immunodeficiency syndrome or organ transplant recipients Human immunodeficiency virus (HIV)-positive patients the researchers considering it inappropriate to participate in the study. Patients with immune system diseases

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment
Interventional Model Description: 50 patients for newly diagnosed group and 50 patients for relapse/refractory group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Newly diagnosed PTCL<br>PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle. | Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine<br>* PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.<br>|
| Other: Relapse/refractory PTCL<br>PD-1 Antibody: 200mg, d1, Chidamide: 30mg, twice a week, Lenalidomide: 10mg, d1-10 gemcitabine:600mg/m2, d1 and 21 days made one treatment cycle. | Drug: PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine<br>* PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | The proportion of patients whose tumor volume has reduced to a predetermined value and can maintain the minimum time limit is the sum of complete and partial mitigation. | From date of randomization until the date tumor volume has reduced, assessed up to 36 months | 
| Progression-free Survival | The time between the start of randomization and the progression of the tumor (any aspect) or (for any reason) death | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | 
| Overall Survival | Time from randomization to death for any reason | From date of randomization until date of death from any cause, assessed up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PD-1, chidamide, lenalidomide, gemcitabine, Peripheral T-cell Lymphoma