Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Study Overview
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Brief Summary
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The purpose of this open label,single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma.

Detailed Description
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Histone deacetylase(HDAC) inhibitor has been used in relapsed or refractory peripheral T-cell lymphoma.There are no international studies of Chidamide combination with lenalidomide for relapsed or refractory peripheral T-cell lymphoma. Therefore, this study intends to select the oral HDAC inhibitor Chidamide combined with lenalidomide for relapsed or refractory peripheral T-cell lymphoma, and explore its efficacy and safety.

Official Title
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Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma: an Open Label, Single Arm, Phase II Study

Conditions
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Relapsed or Refractory Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: Chidamide, Lenalidomide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: peripheral T cell lymphoma (PTCL); no remission or relapse after at least one previous systemic treatment； at least one assessable lesion； 18-75 years; ECOG PS 0-2; proper functioning of the major organs; expected survival time ≥3 months. Exclusion Criteria: previous received treatment of HDAC inhibitor or lenalidomide; central nervous system (CNS) involvement; serious heart problems; known allergies to experimental drug ingredients; diagnosed with or receiving treatment for a malignancy other than lymphoma; uncontrolled active infection, with the exception of tumor-related b-symptom fever; unable or unwilling to receive antithrombotic therapy; history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chidamide combined Lenalidomide<br>Chidamide, 20 mg, twice per week; lenalidomide, 25 mg, d1-21, and rest for 7 days. one treatment cycle per 28 days.For patients with limited lesions and good drug response, local radiotherapy may be assessed by the investigator. | Drug: Chidamide, Lenalidomide<br>* All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Overall Response Rate | 4-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | 4-years | 
| DOR | Duration of Overall Response | 4-years | 
| OS | Overall Survival | 4-years |