Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
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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:
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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;
Primary outcome measure(s)
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0) — from the initiation of the first dose to 28 days after the last dose To identify the incidence of AE and SAE in clinical trial
Trial sites (1)
Facility
City
Region
Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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