Prospective, Single Arm, Single Center Study of Duvelisib Combined With Chidamide in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma (PTCL)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Duvelisib, Chidamide.
- Who it may be relevant to
- Registry conditions: Newly Diagnosed Peripheral T-cell Lymphoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Duvelisib, Chidamide
Duvelisib, 25mg, BID, PO; Chidamide, 20mg, BIW, PO;
Primary outcome measures
- 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]
Secondary outcome measures (5)
- Objective response rate (ORR) [Time frame: up to 26 weeks]
- Complete remission rate (CR) [Time frame: 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]
- 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]
- Overall survival (OS) [Time frame: From date of randomization until the date of death from any cause, assessed up to 20 months]
Eligibility criteria
Inclusion criteria
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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
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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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT05976997 · CSPC-KBT-PTCL-C01