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

T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05075460
• Other study ID #: PUMCH-NHL-010
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2021
• Est. completion date: October 30, 2024

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Yan Zhang
• Phone: +861069156874
• Email: zhangyan10659[@]pumch.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 107
• Est. completion date: October 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• T-cell Lymphoma

Intervention

Drug:
• Tucidinostat, 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

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	the total proportion of patients with complete response (CR) and partial response (PR)	6 course of treatment (each cycle is 21 days)
Secondary	2-year progression-free survival(PFS)	Time from treatment until disease progression or death	2 years
Secondary	2-year overall survival(OS)	Time from treatment until death from any cause	2 years
Secondary	Incidence and severity of adverse events, serious adverse events and other safety parameters	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0	2 years