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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Refractory Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Chidamide, Lenalidomide

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 Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Guangdong General Hospital
      • Contact: Wenyu Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Chidamide, Lenalidomide; All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2020
• Primary Completion (Anticipated): March 26, 2022
• Study Completion (Anticipated): March 26, 2025

Study Registration Dates

• First Submitted: March 28, 2020
• First Submitted That Met QC Criteria: March 28, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Lenalidomide
• Other Study ID Numbers: B2020-013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No