Status:
UNKNOWN
Chidamide Combination With Lenalidomide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Relapsed or Refractory Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 lymphom...
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 ref...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 26 2025
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04329130
Start Date
March 27 2020
End Date
March 26 2025
Last Update
April 24 2020
Active Locations (1)
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1
Guangdong General Hospital
Guangzhou, Guangdong, China, 510000