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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, single arm, single center study, including two phases. It plans to recruit36 patients with clinically diagnosed primary PTCL who will be treated with Duvelisib and Chidamide. In the first phase Duvelisib is Oral administration at a dose of 25mg twice a day, and every 4 weeks (28 days) was a cycle. Next administration will be depend on whether the efficacy reaches CR in the second phase.

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

Conditions
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Newly Diagnosed Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: Duvelisib, Chidamide


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duvelisib-Chidamide<br>Patients with newly diagnosed PTCL were treated with a combination of Duvelisib and Chidamide. The dose of Duvelisib was 25mg twice a day. Every 4 weeks (28 days) is a cycle with a total of 2 cycles. | Drug: Duvelisib, Chidamide<br>* Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0) | To identify the incidence of AE and SAE in clinical trial | from the initiation of the first dose to 28 days after the last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | To evaluate the efficacy of anti-lymphoma | up to 26 weeks | 
| Complete remission rate (CR) | To evaluate the efficacy of anti-lymphoma | up to 26 weeks | 
| Duration of Response（DOR） | To evaluate the efficacy of anti-lymphoma | The time from the first assessment as CR or PR to the first assessment as PD or death (due to any cause)，assessed up to 12 months | 
| Progression free survival (PFS) | To evaluate the efficacy of anti-lymphoma | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months | 
| Overall survival (OS) | To evaluate the efficacy of anti-lymphoma | From date of randomization until the date of death from any cause, assessed up to 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duvelisib, Chidamide, Peripheral T-cell Lymphoma