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Clinical Trials in China / NCT05976997
Recruiting Phase 2

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

NCT05976997 · tracked via the Priya Life Science China tracker
Sponsor
Liling Zhang
Phase
Phase 2
Started
2023-05-08
Last updated
2026-05-18

Condition(s) studied

Newly Diagnosed Peripheral T-cell Lymphoma

Investigational drug(s) / intervention(s)

Duvelisib, Chidamide

Duvelisib, Chidamide: Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting

More Liling Zhang trials in China

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Official registry record

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.

View NCT05976997 on ClinicalTrials.gov ↗ ← All trials in China