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

Phase 2

Recruiting

• Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma
• Interventions: Drug: Chidamide, Lenalidomide

• Registration Number: NCT04329130
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-27
• Study First Submitted: 2020-03-28
• Study First Submitted QC: 2020-03-28
• Status Verified: 2020-04
• Study First Posted: 2020-04-01
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24
• Primary Completion: 2022-03-26
• Study Completion: 2025-03-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide combined Lenalidomide	Chidamide, Lenalidomide	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.

Primary Outcome Measures

Name	Time	Method
ORR	4-years	Overall Response Rate

Secondary Outcome Measures

Name	Time	Method
DOR	4-years	Duration of Overall Response
OS	4-years	Overall Survival
PFS	4-years	Progression Free Survival

Trial Locations

Locations (1)

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China