Actively Recruiting
Chidamide and Duvalisibon for the Treatment of Refractory/Relapsed Peripheral T-cell Lymphoma
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
33
Participants Needed
1
Research Sites
213 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
To determine the efficacy and safety of Chidamide combined with Duvalisib in the treatment of refractory/relapsed peripheral T-cell lymphoma.
CONDITIONS
Official 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 2008 WHO classification
- Relapsed or refractory patients who have received at least first-line anthracycline-containing systemic treatment
- At least one measurable lesion larger than 1.5 cm according to Lugano 2014 criteria
- Aged 18 to 75 years
- ECOG performance status between 0 and 2
- Absolute neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥ 75 × 10^9/L, hemoglobin ≥ 80 g/L
- Expected survival of at least 3 months
- No radiotherapy, chemotherapy, targeted therapy, or stem cell transplant within 4 weeks before enrollment
- Written informed consent provided by patient or legal representative
You will not qualify if you...
- Central nervous system or meningeal invasion
- Laboratory abnormalities including ANC < 1.5 × 10^9/L, hemoglobin < 80 g/L, platelet count < 75 × 10^9/L, or significant organ dysfunction
- Elevated INR > 1.5 ULN or APTT > 1.5 ULN
- Active HIV, hepatitis B or C infection except controlled HBV or HCV as specified
- Positive CMV IgM and CMV DNA by PCR
- Significant cardiac conditions including arrhythmias, QTcF > 480 msec, recent myocardial infarction, or NYHA class 3 or above heart failure
- History of stroke or intracranial hemorrhage within 6 months
- Major surgery within 4 weeks before first drug administration
- Prior use of PI3K inhibitors with disease progression during treatment
- Recent systemic anti-tumor therapy or radiotherapy within 4 weeks
- Participation in other drug clinical trials within 2 weeks or targeted drug use within 4 weeks
- Hematopoietic stem cell transplantation within specified timelines
- Use of strong CYP3A4 inducers or inhibitors within 2-3 weeks before drug administration
- Unresolved toxicities from prior anti-tumor therapy above grade 1 except hair loss
- Uncontrolled systemic infection requiring IV antibiotics
- Other active primary tumors needing treatment
- Inability to take oral drugs due to gastrointestinal conditions
- Pregnant or breastfeeding women
- Any other significant disease or condition judged unsuitable by the investigator
AI-Screening
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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
CONTACT
Z
Zhifeng Li
CONTACT
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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