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

May 14, 2026 updated by: Liling Zhang
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Principal Investigator:
          • Liling Zhang, M.D
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety: Hematologic and non-hematologic toxicities (NCI CTCAE v5.0)
Time Frame: 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
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)
Time Frame: up to 26 weeks
To evaluate the efficacy of anti-lymphoma
up to 26 weeks
Complete remission rate (CR)
Time Frame: up to 26 weeks
To evaluate the efficacy of anti-lymphoma
up to 26 weeks
Duration of Response（DOR）
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: From date of randomization until the date of death from any cause, assessed up to 20 months
To evaluate the efficacy of anti-lymphoma
From date of randomization until the date of death from any cause, assessed up to 20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liling Zhang

Collaborators

CSPC Ouyi Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Liling Zhang, M.D, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2023

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 16, 2023

First Submitted That Met QC Criteria

July 27, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPC-KBT-PTCL-C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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