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

Liling Zhang

Status and phase: Enrolling; Phase 2

Conditions: Newly Diagnosed Peripheral T-cell Lymphoma

Treatments: Drug: Duvelisib, Chidamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05976997

CSPC-KBT-PTCL-C01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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;

  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;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Duvelisib-Chidamide

Experimental group

Description:

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.

Treatment:

Drug: Duvelisib, Chidamide