Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
Recruiting now · Phase 2
Conditions studied: Newly Diagnosed Peripheral T-cell Lymphoma
In brief
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.
Key facts
- Study ID
- NCT05976997
- Run by
- Liling Zhang
- People needed
- 36
- Starts
- 2023-05-08
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-05-18
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
You may not qualify if…
- 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;
Where it is running
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
Full record on ClinicalTrials.gov
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