Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a prospective, single arm, single center study to evaluate the efficacy and safety of Duvelisib combined with Chidamide in the treatment of newly diagnosed peripheral T-cell lymphoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
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• Age: 18-70 Years (Contains boundary values 18 and 70);
• 2.The newly diagnosed PTCL confirmed by histopathology is one of the following subtypes;
• a) Angioimmunoblastic T-cell lymphoma (AITL); b) Follicular T helper cell lymphoma (T-FHCL); Including but not limited to the above two subtypes;
• 3.ECOG ≤ 3;
• 4.At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
• 5.Expected survival ≥ 3 months;
• 6.Subjects fully understand and voluntarily participate in this study and sign informed consent;
Locations
Other Locations
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Liling Zhang, M.D
lily1228@sina.com
0086 27 83262660
Time Frame
Start Date: 2023-05-08
Estimated Completion Date: 2026-12
Participants
Target number of participants: 36
Treatments
Experimental: Duvelisib-Chidamide
Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles.
Related Therapeutic Areas
Sponsors
Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.
Leads: Liling Zhang