Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
Newly Diagnosed Peripheral T-cell Lymphoma
About this trial
This is an interventional treatment trial for Newly Diagnosed Peripheral T-cell Lymphoma focused on measuring Duvelisib, Chidamide, Peripheral T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: - 1.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; Exclusion Criteria: - 1.Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment; 2.Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS; 3.Significant active heart disease within the past 6 months, including: New York Heart Association (NYHA) Class III/IV congestive heart failure unstable angina pectoris or angina requiring surgical or medication intervention, and/or myocardial infarction; 4.Uncontrolled systemic fungal, bacterial, or viral infections (defined as persistent signs/symptoms related to infection that have not improved despite the use of appropriate antibiotics, antiviral therapy, and/or other treatments); 5.Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction; 6.Subjects with any other active malignant tumor at the time of screening, except for adequately treated cervical Carcinoma in situ or breast cancer Carcinoma in situ, skin Basal-cell carcinoma or local skin squamous cell carcinoma; 7.Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study; 8.Any serious uncontrolled systemic disease; 9.increasing the risk of the subject or interfering with the test results determined by the investigator;
Sites / Locations
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
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.