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

Relapsed or Refractory Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04329130
• Other study ID #: B2020-013
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2020
• Est. completion date: March 26, 2025

Study information

• Verified date: April 2020
• Source: Sun Yat-sen University
• Contact: Qingqing Cai, MD
• Phone: 0086-20-87342823
• Email: caiqq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: March 26, 2025
• Est. primary completion date: March 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Relapsed or Refractory Peripheral T-cell Lymphoma

Intervention

Drug:
• Chidamide, Lenalidomide
All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.

Locations

Country	Name	City	State
China	Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	Overall Response Rate	4-years
Secondary	PFS	Progression Free Survival	4-years
Secondary	DOR	Duration of Overall Response	4-years
Secondary	OS	Overall Survival	4-years