Status:
UNKNOWN
Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
Lead Sponsor:
Liling Zhang
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Newly Diagnosed Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- \-
- Age: 18-70 Years (Contains boundary values 18 and 70);
- 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;
- ECOG ≤ 3;
- At least one measurable or evaluable tumor lesion according to the Lugano-2014 standard;
- Expected survival ≥ 3 months;
- Subjects fully understand and voluntarily participate in this study and sign informed consent;
Exclusion
- \-
- Subjects who have previously received systemic treatment for lymphoma or currently undergoing anticancer treatment;
- Subjects with central nervous system (CNS) lymphoma or lymphoma involving CNS;
- 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;
- 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);
- Human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection and history of severe skin reaction;
- 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;
- Pregnant women, lactating women, patients who refused to take effective contraceptive measures during the study;
- Any serious uncontrolled systemic disease;
- increasing the risk of the subject or interfering with the test results determined by the investigator;
Key Trial Info
Start Date :
May 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT05976997
Start Date
May 8 2023
End Date
December 1 2024
Last Update
August 4 2023
Active Locations (1)
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1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022