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

Sponsor

Liling Zhang (Other)

Overall Status

Recruiting

CT.gov ID

NCT05976997

Collaborator

CSPC Ouyi Pharmaceutical Co., Ltd. (Industry)

Enrollment

Location

Arm

18.8

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Newly Diagnosed Peripheral T-cell Lymphoma	Drug: Duvelisib, Chidamide	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 8, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duvelisib-Chidamide 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 Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;

Arm

Intervention/Treatment

Experimental: Duvelisib-Chidamide

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Objective response rate (ORR) [up to 26 weeks]
To evaluate the efficacy of anti-lymphoma
Complete remission rate (CR) [up to 26 weeks]
To evaluate the efficacy of anti-lymphoma
Duration of Response（DOR） [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]
To evaluate the efficacy of anti-lymphoma
Progression free survival (PFS) [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]
To evaluate the efficacy of anti-lymphoma
Overall survival (OS) [From date of randomization until the date of death from any cause, assessed up to 20 months]
To evaluate the efficacy of anti-lymphoma

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

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;