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

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

Study Overview

• Status: Recruiting
• Conditions: T-cell Lymphoma
• Intervention / Treatment: Drug: Tucidinostat, Azacitidine combined with CHOP

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 Type: Interventional
• Enrollment (Estimated): 107
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yan Zhang; Phone Number: +861069156874; Email: zhangyan10659@pumch.cn
• Study Contact Backup: Name: Daobin Zhou; Phone Number: +861069156874; Email: zhoudb@pumch.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking Union Medical College Hospital
    • Contact: Daobin Zhou, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tucidinostat, Azacitidine combined with CHOP	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
Active Comparator: CHOP	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Chair: Daobin Zhou, Department of Hematology, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): October 30, 2024

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 6, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Azacitidine; CHOP; Tucidinostat
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Azacitidine
• Other Study ID Numbers: PUMCH-NHL-010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No