A Prospective, Multicenter, Phase III, Non-randomized Study of Tucidinostat, Azacitidine Combined With CHOP Versus CHOP in Patients With Untreated Peripheral T-cell Lymphoma
Who is this study for? Patients with untreated peripheral T-cell lymphoma
What treatments are being studied? Tucidinostat+Azacitidine+CHOP
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Yan Zhang
zhangyan10659@pumch.cn
+861069156874
Backup
Daobin Zhou
zhoudb@pumch.cn
+861069156874
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2024-10-30
Participants
Target number of participants: 107
Treatments
Experimental: Tucidinostat, Azacitidine combined with CHOP
Tucidinostat, Azacitidine combined with CHOP
Active_comparator: CHOP
CHOP
Related Therapeutic Areas
Sponsors
Leads: Peking Union Medical College Hospital