NCT05976997 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 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Liling Zhang |
| Condition | Newly Diagnosed Peripheral T-cell Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2023-05-08 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2023-05-08 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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;
Contact & Investigator
Liling Zhang, M.D
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT05976997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Newly Diagnosed Peripheral T-cell Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05976997 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05976997 currently recruiting?
Yes, NCT05976997 is actively recruiting participants. Contact the research team at lily1228@sina.com for enrollment information.
Where is the NCT05976997 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05976997 clinical trial?
NCT05976997 is sponsored by Liling Zhang. The principal investigator is Liling Zhang, M.D at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 36 participants.