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

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

This study is testing if a combination of two medications, Duvelisib and Chidamide, can effectively treat people who have just been diagnosed with peripheral T-cell lymphoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Huazhong University of Science and Technology (Academic / other)
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05976997 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with newly diagnosed peripheral T-cell lymphoma confirmed by histopathology.

Not a fit: Patients who have previously received systemic treatment for lymphoma or have central nervous system involvement will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with newly diagnosed peripheral T-cell lymphoma.

How similar studies have performed: While there have been studies on Duvelisib and Chidamide individually, this specific combination for newly diagnosed peripheral T-cell lymphoma is novel and has not been extensively tested.

Eligibility criteria

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 this trial is running

Wuhan, Hubei

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

Study contacts

• Principal investigator: Liling Zhang, M.D — Wuhan Union Hospital, China
• Study coordinator: Liling Zhang, M.D

Conditions Newly Diagnosed Peripheral T-cell Lymphoma; Duvelisib; Chidamide; Peripheral T-cell Lymphoma