A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 107
- Locations
- 1
- Primary Endpoint
- Overall response rate (ORR)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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 × 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
Arms & Interventions
Tucidinostat, Azacitidine combined with CHOP
Tucidinostat, Azacitidine combined with CHOP
Intervention: Tucidinostat, Azacitidine combined with CHOP (Drug)
CHOP
CHOP
Intervention: Tucidinostat, Azacitidine combined with CHOP (Drug)
Outcomes
Primary Outcomes
Overall response rate (ORR)
Time Frame: 6 course of treatment (each cycle is 21 days)
the total proportion of patients with complete response (CR) and partial response (PR)
Secondary Outcomes
- Incidence and severity of adverse events, serious adverse events and other safety parameters(2 years)
- 2-year overall survival（OS）(2 years)
- 2-year progression-free survival（PFS）(2 years)
Investigators
Yan Zhang, MD
Deputy Chief Physician
Peking Union Medical College Hospital