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

NCT ID: NCT04329130

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-27
• Study Completion Date: 2025-03-26

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.

Conditions

Relapsed or Refractory Peripheral T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide combined 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.

Group Type: EXPERIMENTAL

Chidamide, Lenalidomide

Intervention Type: DRUG

All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.

Interventions

Chidamide, Lenalidomide

All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Qingqing Cai

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Qingqing Cai, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qingqing Cai, MD

Role: CONTACT

caiqq@sysucc.org.cn

0086-20-87342823

Facility Contacts

Wenyu Li, MD

Role: primary

Other Identifiers

B2020-013

Identifier Type: -

Identifier Source: org_study_id