Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)

CSPC-KBT-PTCL-C01

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.

2023-05-08

2023-12-01

2024-12-01

Recruiting

Early phase I

36

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;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 36, 'type': 'ESTIMATED'}}

2023-08-04