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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04329130

Enrollment

Registered

2020-04-01

Start date

2020-03-27

Completion date

2025-03-26

Last updated

2020-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Peripheral T-cell Lymphoma

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.

Interventions

DRUGChidamide, Lenalidomide

All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
ORR	4-years	Overall Response Rate

Secondary

Measure	Time frame	Description
PFS	4-years	Progression Free Survival
DOR	4-years	Duration of Overall Response
OS	4-years	Overall Survival

Countries

China

Contacts

Primary ContactQingqing Cai, MD

caiqq@sysucc.org.cn0086-20-87342823

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026