Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

Phase 3

Recruiting

• Conditions: T-cell Lymphoma
• Interventions: Drug: Tucidinostat, Azacitidine combined with CHOP

• Registration Number: NCT05075460
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

This is a prospective, multicenter, phase III study of Tucidinostat, Azacitidine combined with CHOP versus CHOP in patients with untreated peripheral T-cell lymphoma

Detailed Description

Tucidinostat, a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. Azacytidine is a hypomethylating agent. The aim of this study is to compare the efficacy and safety of azacytidine, tucidinostat combined with CHOP regimen and classical CHOP regimen in the treatment of primary PTCL

Study Timeline

• Study First Submitted: 2021-09-22
• Study Start: 2021-10-01
• Study First Submitted QC: 2021-10-09
• Study First Posted: 2021-10-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-06
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-05-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

• Patients with peripheral T-cell lymphoma confirmed by primary pathology;
• Age 18-70 years;
• ECOG performance status ≤ 2;
• Adequate bone marrow hematopoietic function: WBC > 3.5 × 10*9/L，ANC>1.5 × 10*9/L，HGB>90g/L，PLT>80 × 10*9/L;
• Adequate organ function: cardiac function grade 0-2 (NYHA); SpO2 > 88% (natural condition); ALT<3UNL，TBil<2ULN; SCr>60ml/min/m2;
• Patients have signed the Informed Consent Form

Exclusion Criteria

• ALK positive anaplastic T-cell lymphoma;
• NK / T cell lymphoma, nasal type;
• Uncontrolled active infection;
• Acute myocardial infarction or unstable angina pectoris within 6 months; uncontrolled hypertension, symptomatic arrhythmia, etc;
• Subjects who are known or suspected to be unable to comply with the study protocol;
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tucidinostat, Azacitidine combined with CHOP	Tucidinostat, Azacitidine combined with CHOP	Tucidinostat, Azacitidine combined with CHOP
CHOP	Tucidinostat, Azacitidine combined with CHOP	CHOP

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	6 course of treatment (each cycle is 21 days)	the total proportion of patients with complete response (CR) and partial response (PR)

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events, serious adverse events and other safety parameters	2 years	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
2-year overall survival（OS）	2 years	Time from treatment until death from any cause
2-year progression-free survival（PFS）	2 years	Time from treatment until disease progression or death

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China