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

NCT ID: NCT05976997

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2024-12-31

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.

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.

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Duvelisib, Chidamide

Intervention Type: DRUG

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

Interventions

Duvelisib, Chidamide

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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Liling Zhang

OTHER

Sponsor Role: lead

Responsible Party

Liling Zhang

chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Liling Zhang, M.D

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liling Zhang, M.D

Role: CONTACT

15871725926lily1228@sina.com

15871725926

Facility Contacts

Liling Zhang, M.D

Role: primary

15871725926lily1228@sina.com

15871725926

Other Identifiers

CSPC-KBT-PTCL-C01

Identifier Type: -

Identifier Source: org_study_id