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RECRUITINGPHASE2

Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma

A Multicenter, Prospective and Single-arm Clinical Study on the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma (R/R PTCL) With Chidamide and Duvalisib

NCT06151106•The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

Summary

To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.

Detailed Description

This is a Phase 2, open-label clinical trial study that aims to evaluate the efficacy (Overall Response Rate, Complete Response, Partial Response, Overall Survival, Progression Free Survival) and adverse effects of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the classification standard of the World Health Organization in 2008
•2. Relapsed and refractory patients who have received at least first-line systemic treatment with anthracycline-containing drugs in the past. Recurrence is defined as relapse after CR or progression after PR, SD. The refractory disease was defined as previous systemic chemotherapy, PD in response evaluation for 2 cycles or SD in response evaluation for 4 cycles.
•3. There must be at least one evaluable or measurable lesion meeting Lugano2014 standard: lymph node lesion and the measurable lymph node length should be \> 1.5cm;
•4. Patients aged at 18-75 years old;
•5. ECOG 0-2
•6. Routine blood examination: absolute neutrophil count ≥ 1.5× 10 9/L, platelet ≥ 75x10 9/L, Hb ≥ 80g/L.
•7. Expected survival ≥3 months 8 No radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation was received within 4 weeks before enrollment.
•9\. The patient or his/her legal representative must provide written informed consent before carrying out any special inspection or procedure of the study.

Exclusion Criteria

•1. Patients with central nervous system (CNS) or meningeal invasion
•2. Any of the following laboratory abnormalities: absolute neutrophil count (ANC) \< 1.5× 10\*9/L, Hb\< 80 g/L, PLT \< 75×10 9 /L, organ dysfunction, are defined as follows: total bilirubin (TBiL) \> 1.5 upper limit of normal value (ULN), or AST or ALT \>2.5ULN, except the following situations. if patients with liver infiltrated by lymphoma cells, AST and ALT \< 5ULN could be enrolled.
•3. International normalized ratio (INR)\>1.5ULN or partially activated prothrombin time (APTT) \> 1.5 ULN
•4. The active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) should be excluded except for the following patients: patients with HBV infection (HBsAg or HBcAg positive) but HBV DNA negative. These patients need continuous antiviral treatment and HBV DNA PCR detection every cycle. additionally, patients with HCV serology positive but HCV RNA negative can be enrolled.
•5. In patients with CMV infection (IgM positive), CMV DNA was positive by PCR.
•6. Meet any of the following criteria related to visceral function: all kinds of clinically significant abnormal rhythm or conduction need clinical pre-diagnosis Hereditary QT interval syndrome or QTcF\>480 msec or taking drugs that may cause Qt interval delay or torsade de pointes. A variety of clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina, and coronary artery bypass grafting in the first 6 months of the group, with New York's cardiology (NYHA) classification of grade 3 or above. Left ventricular ejection fraction (LVEF )\<40%, or uncontrolled blood pressure controlled by drugs (Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mgHg).
•7. Have a history of stroke or intracranial hemorrhage within 6 months before drug administration for the first time
•8. Major surgery was performed within 4 weeks before drug administration for the first study
•9. Any PI3K inhibitor has been used before and the disease has progressed during the treatment period (within 6 months after the last use)
•10. Received systemic anti-tumor therapy or radiotherapy within 4 weeks before the first study drug administration
+10 more criteria

Locations (1)

The First Affiliated Hosptial of Xiamen University

Xiamen, Fujian, China

Key Dates

Start Date

November 22, 2023

Primary Completion Date

December 31, 2026

Completion Date

December 25, 2027

Last Updated

February 19, 2025

Enrollment

ESTIMATED participants

Conditions

Peripheral T Cell LymphomaRelapsed Peripheral T-Cell LymphomaRefractory T-Cell Lymphoma

Interventions

Chidamide combined with Duvillisib

DRUG

Contacts

Bing Xu

CONTACT

+8618750918842 xubingzhangjian@126.com

Zhifeng Li

CONTACT

+8613606901162 lzf_xm@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma

Inclusion Criteria

Exclusion Criteria

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