Combining Duvelisib and Chidamide for Newly Diagnosed Peripheral T-cell Lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of Duvelisib combined with Chidamide in treating patients with newly diagnosed peripheral T-cell lymphoma. It is a prospective, single-arm study that aims to recruit 36 patients who will receive Duvelisib orally at a dose of 25mg twice daily for 28-day cycles. The treatment's continuation will depend on the efficacy observed in the second phase, specifically if complete response (CR) is achieved. The study is conducted at a single center, ensuring focused monitoring and assessment of outcomes.

Why it matters

Who can join: the full rules

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;

Where it's running

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

Study contacts

• Principal investigator: Liling Zhang, M.D — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Liling Zhang, M.D
• Email: lily1228@sina.com
• Phone: 0086 27 83262660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.