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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05075460
Collaborator
(none)
107
Enrollment
2
Arms
37
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Tucidinostat, Azacitidine combined with CHOP
 Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tucidinostat, Azacitidine combined with CHOP

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

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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 2-year progression-free survival（PFS） [2 years]

    Time from treatment until disease progression or death

  2. 2-year overall survival（OS） [2 years]

    Time from treatment until death from any cause

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 × 109/L，ANC>1.5 × 109/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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Study Chair: Daobin Zhou, Department of Hematology, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YanZhang, Deputy Chief Physician, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT05075460
Other Study ID Numbers:
  • PUMCH-NHL-010
First Posted:
Oct 12, 2021
Last Update Posted:
Oct 12, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by YanZhang, Deputy Chief Physician, Peking Union Medical College Hospital
Tucidinostat
Azacitidine
CHOP
Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Azacitidine

Study Results

No Results Posted as of Oct 12, 2021