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

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

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.

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.

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;