Actively Recruiting
A Multicenter, Prospective and Single-arm Clinical Study on the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma With Chidamide and Duvalisib
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
33
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
F
Fujian Cancer Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining Chidamide with Duvalisib to treat adults with refractory or relapsed peripheral T-cell lymphoma, a type of blood cancer. This Phase 2, open-label clinical trial focuses on measuring overall response rates, including complete and partial responses, as well as survival outcomes. The study aims to provide insights into how well this drug combination works and its side effects in patients who have not responded to previous treatments. Participants receive a specified dose of Chidamide combined with Duvalisib according to the trial schedule. The study is conducted as a single-arm trial without a placebo group, meaning all participants receive the combined treatment. The treatment period and dosing details are carefully monitored to assess the response to therapy over time. Throughout the study, participants will undergo regular evaluations including blood tests and imaging to measure tumor response and track side effects. Key outcomes like overall response rate and survival will be followed for up to 27 months. The trial also includes monitoring of safety and adverse effects to ensure participant well-being. The total duration for each participant depends on their response and study protocol adherence.
CONDITIONS
Brief Title
Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Peripheral T-cell lymphoma (PTCL) or NK/T-cell lymphoma confirmed by histopathology/cytology according to the World Health Organization 2008 classification
- Relapsed or refractory patients who have received at least one prior systemic treatment containing anthracycline drugs
- At least one measurable lesion according to Lugano 2014 criteria, with lymph node length > 1.5 cm
- Aged between 18 and 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate blood counts: neutrophils ≥ 1.5 x 10⁹/L, platelets ≥ 75 x 10⁹/L, hemoglobin ≥ 80 g/L
- Expected survival of at least 3 months
- No radiotherapy, chemotherapy, targeted therapy, or stem cell transplantation within 4 weeks before enrollment
- Written informed consent provided by patient or legal representative
You will not qualify if you...
- Central nervous system (CNS) or meningeal invasion
- Laboratory abnormalities: neutrophils < 1.5 x 10⁹/L, hemoglobin < 80 g/L, platelets < 75 x 10⁹/L, or significant organ dysfunction
- Coagulation abnormalities: INR > 1.5 ULN or APTT > 1.5 ULN
- Active infections: HIV, HBV with detectable DNA, active HCV RNA, or CMV DNA positive
- Significant heart conditions including severe arrhythmias, QT prolongation, recent myocardial infarction, or heart failure NYHA grade 3 or above
- Stroke or intracranial hemorrhage within 6 months
- Major surgery within 4 weeks prior to study drug administration
- Prior use of PI3K inhibitors with disease progression within 6 months
- Recent systemic anti-tumor therapy or radiotherapy within 4 weeks
- Participation in other drug trials within 2 weeks or targeted therapy within 4 weeks
- Recent stem cell transplantation or active graft-versus-host disease
- Use of strong CYP3A4 inducers or inhibitors within 2 weeks prior to treatment
- Unrecovered toxic effects from prior anti-tumor therapy above grade 1 (except alopecia)
- Uncontrolled infections requiring intravenous antibiotics
- Presence of other primary tumors needing active treatment
- Inability to take oral medication due to gastrointestinal issues
- Pregnant or breastfeeding women
- Any other medical condition judged by the investigator to interfere with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 27 months
Participants receive Chidamide combined with Duvalisib according to the specified dosing schedule to treat refractory/relapsed peripheral T-cell lymphoma.
Visits scheduled as per treatment protocol
Trial Site Locations
Total: 1 location
1
The First Affiliated Hosptial of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
Z
Zhifeng Li
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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