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

Primary Purpose

Relapsed or Refractory Peripheral T-cell Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide, Lenalidomide
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Refractory Peripheral T-cell Lymphoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide combined Lenalidomide

Arm Description

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.

Outcomes

Primary Outcome Measures

ORR
Overall Response Rate

Secondary Outcome Measures

PFS
Progression Free Survival
DOR
Duration of Overall Response
OS
Overall Survival

Full Information

First Posted
March 28, 2020
Last Updated
April 22, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04329130
Brief Title
Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Official Title
Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma: an Open Label, Single Arm, Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2020 (Actual)
Primary Completion Date
March 26, 2022 (Anticipated)
Study Completion Date
March 26, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Peripheral T-cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chidamide combined Lenalidomide
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chidamide, Lenalidomide
Intervention Description
All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.
Primary Outcome Measure Information:
Title
ORR
Description
Overall Response Rate
Time Frame
4-years
Secondary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
4-years
Title
DOR
Description
Duration of Overall Response
Time Frame
4-years
Title
OS
Description
Overall Survival
Time Frame
4-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, MD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qingqing Cai, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyu Li, MD

12. IPD Sharing Statement

Learn more about this trial

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

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