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

A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05075460

Enrollment

107

Registered

2021-10-12

Start date

2021-10-01

Completion date

2024-10-30

Last updated

2024-04-09

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

Conditions

T-cell Lymphoma

Keywords

Tucidinostat, Azacitidine, CHOP

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

Interventions

DRUGTucidinostat, Azacitidine combined with CHOP

Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast. CHOP chemotherapy: * Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1; * Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1; * Vinoresin (VDS) 4mg intravenous infusion, day 1; * Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
2-year progression-free survival（PFS）	2 years	Time from treatment until disease progression or death
2-year overall survival（OS）	2 years	Time from treatment until death from any cause
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

Countries

China

Contacts

Primary ContactYan Zhang

zhangyan10659@pumch.cn+861069156874

Backup ContactDaobin Zhou

zhoudb@pumch.cn+861069156874

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026