search
Back to results

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

Primary Purpose

T-cell Lymphoma

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tucidinostat, Azacitidine combined with CHOP
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for T-cell Lymphoma focused on measuring Tucidinostat, Azacitidine, CHOP

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tucidinostat, Azacitidine combined with CHOP

    CHOP

    Arm Description

    Tucidinostat, Azacitidine combined with CHOP

    CHOP

    Outcomes

    Primary Outcome Measures

    Overall response rate (ORR)
    the total proportion of patients with complete response (CR) and partial response (PR)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    September 22, 2021
    Last Updated
    October 9, 2021
    Sponsor
    Peking Union Medical College Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05075460
    Brief Title
    Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    October 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    T-cell Lymphoma
    Keywords
    Tucidinostat, Azacitidine, CHOP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    107 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tucidinostat, Azacitidine combined with CHOP
    Arm Type
    Experimental
    Arm Description
    Tucidinostat, Azacitidine combined with CHOP
    Arm Title
    CHOP
    Arm Type
    Active Comparator
    Arm Description
    CHOP
    Intervention Type
    Drug
    Intervention Name(s)
    Tucidinostat, Azacitidine combined with CHOP
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Overall response rate (ORR)
    Description
    the total proportion of patients with complete response (CR) and partial response (PR)
    Time Frame
    6 course of treatment (each cycle is 21 days)
    Secondary Outcome Measure Information:
    Title
    2-year progression-free survival（PFS）
    Description
    Time from treatment until disease progression or death
    Time Frame
    2 years
    Title
    2-year overall survival（OS）
    Description
    Time from treatment until death from any cause
    Time Frame
    2 years
    Title
    Incidence and severity of adverse events, serious adverse events and other safety parameters
    Description
    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yan Zhang
    Phone
    +861069156874
    Email
    zhangyan10659@pumch.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daobin Zhou
    Phone
    +861069156874
    Email
    zhoudb@pumch.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Daobin Zhou
    Organizational Affiliation
    Department of Hematology, Peking University First Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs