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

NCT05075460 | Recruiting Phase 3

• 1 other identifier: PUMCH-NHL-010
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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

Conditions

T-cell Lymphoma

Keywords

Tucidinostat; Azacitidine; CHOP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 2-year progression-free survival（PFS）

  2 years

• 2-year overall survival（OS）

  2 years

• Incidence and severity of adverse events, serious adverse events and other safety parameters

  2 years

Study Arms (2)

Tucidinostat, Azacitidine combined with CHOP

EXPERIMENTAL

Tucidinostat, Azacitidine combined with CHOP

Drug: Tucidinostat, Azacitidine combined with CHOP

CHOP

ACTIVE COMPARATOR

CHOP

Drug: Tucidinostat, Azacitidine combined with CHOP

Interventions

Tucidinostat, Azacitidine combined with CHOP DRUG

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

CHOP; Tucidinostat, Azacitidine combined with CHOP

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

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

• Daobin Zhou

  Department of Hematology, Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Yan Zhang

CONTACT

+861069156874; zhangyan10659@pumch.cn

Daobin Zhou

CONTACT

+861069156874; zhoudb@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 12, 2021
• Study Start: October 1, 2021
• Primary Completion: May 30, 2024
• Study Completion: October 30, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Locations

CN (1)