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

NCT06151106 | Recruiting Phase 2

• 1 other identifier: XMDYYYXYK-02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peripheral T Cell Lymphoma; Relapsed Peripheral T-Cell Lymphoma; Refractory T-Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate

  Percentage of participants with best overall response of partial response (PR) and complete response (CR), using the Lugano criteria.

  Up to 27 months

• Complete Response Rate

  Complete response (CR) is evaluated according to the Lugano criteria for lymphoma response.

  Up to 27 months

Secondary Outcomes (3)

• Partial Response Rate

  Up to 27 months

• Progression Free Survival

  Up to 27 months

• Overall Survival

  Up to 27 months

Study Arms (1)

Chidamide combined with Duvillisib

EXPERIMENTAL

Drug: Chidamide combined with Duvillisib

Interventions

Chidamide combined with Duvillisib DRUG

Specified dose on specified days

Chidamide combined with Duvillisib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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;
• Patients aged at 18-75 years old;
• ECOG 0-2
• Routine blood examination: absolute neutrophil count ≥ 1.5× 10 9/L, platelet ≥ 75x10 9/L, Hb ≥ 80g/L.
• Expected survival ≥3 months 8 No radiotherapy, chemotherapy, targeted therapy, or hematopoietic stem cell transplantation was received within 4 weeks before enrollment.
• \. The patient or his/her legal representative must provide written informed consent before carrying out any special inspection or procedure of the study.

You may not qualify if:

• Patients with central nervous system (CNS) or meningeal invasion
• 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.
• International normalized ratio (INR)\>1.5ULN or partially activated prothrombin time (APTT) \> 1.5 ULN
• 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.
• In patients with CMV infection (IgM positive), CMV DNA was positive by PCR.
• 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).
• Have a history of stroke or intracranial hemorrhage within 6 months before drug administration for the first time
• Major surgery was performed within 4 weeks before drug administration for the first study
• Any PI3K inhibitor has been used before and the disease has progressed during the treatment period (within 6 months after the last use)
• Received systemic anti-tumor therapy or radiotherapy within 4 weeks before the first study drug administration
• The last time you participated in clinical trials of other drugs before the administration of the first study drug was less than 2 weeks or the last time you used targeted drugs (such as antibody drugs) was less than 4 weeks
• patients received the transplantation of somatic hematopoietic stem cells within 3 months before the first drug administration
• Patients received allogeneic hematopoietic stem cell transplantation or having any active graft-versus-host disease within 6 months before first drug administration.
• Take a strong inducer or inhibitor of cytochrome P4503A4 (CYP3A4) within 2 weeks before drug administration (3 weeks for Hypericum perforatum) for the first time.
• Before the first enrollment, the toxic reaction of previous anti-tumor therapy has not recovered to ≤1 level (except alopecia).

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead
• Fujian Cancer Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Dongguan People's Hospital: collaborator
• Huizhou Municipal Central Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Sun Yat-sen University: collaborator
• Shanxi Province Cancer Hospital: collaborator

Study Sites (1)

The First Affiliated Hosptial of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

+8618750918842; xubingzhangjian@126.com

Zhifeng Li

CONTACT

+8613606901162; lzf_xm@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: November 30, 2023
• Study Start: November 22, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 25, 2027
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)