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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2024-10-30

Brief Summary

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

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Detailed Description

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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

Conditions

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T-cell Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tucidinostat, Azacitidine combined with CHOP

Group Type EXPERIMENTAL

Tucidinostat, Azacitidine combined with CHOP

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Tucidinostat, Azacitidine combined with CHOP

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No