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

Last updated: April 22, 2020
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

2

Condition

Non-hodgkin's Lymphoma

Lymphoma

Treatment

N/A

Clinical Study ID

NCT04329130
B2020-013
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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 12months;

Study Design

Total Participants: 44
Study Start date:
March 27, 2020
Estimated Completion Date:
March 26, 2025

Study 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.

Connect with a study center

  • Guangdong General Hospital

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

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