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

• Status: Not yet recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Azacitidine

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