Actively Recruiting
Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-20
47
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
CONDITIONS
Official Title
Chidamide Combined With Brentuximab Vedotin Regimen for CD30+ PTCL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 70 years or older, or under 70 years but unfit for chemotherapy, any gender
- Ability to understand and willingly provide written informed consent
- ECOG performance status score between 0 and 3
- Expected lifespan longer than 3 months
- Confirmed diagnosis of CD30-positive peripheral T-cell lymphoma using 2022 WHO classification
- Measurable lesions with a short diameter of at least 15 mm as shown by PET/CT
- Relapsed or refractory PTCL with at least one prior treatment failure and no previous use of chidamide or brentuximab vedotin
- Unfit for chemotherapy after evaluation or not considered for chemotherapy for other reasons
- Any non-blood related side effects from prior treatment, except hair loss, must be resolved to grade 1 or better according to NCI CTCAE v5.0
- Adequate organ function including heart, liver, kidney, and lung function meeting specified levels
- Adequate bone marrow function with specified minimum blood counts and CD34+ cell number
- Willingness to use contraception from study registration until study follow-up
- Good compliance with study procedures
You will not qualify if you...
- Previous use of chidamide and brentuximab vedotin or any anti-tumor therapy within 4 weeks
- Participation in another clinical study within 4 weeks
- HIV infection or active hepatitis B or C
- Uncontrolled active infections
- Severe liver or kidney dysfunction with lab values more than 3 times the upper limit of normal
- Presence of organic heart disease or severe arrhythmia causing symptoms or abnormal heart function (NYHA class 2 or higher)
- Having other tumors requiring treatment or intervention
- History of vascular embolism
- Pregnant or breastfeeding women
- Severe immune suppression
- Psychological conditions preventing participation or signing consent
- Unlikely to complete all study visits and procedures or not meeting study participation requirements
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
Research Team
Z
Zhengming Jin
CONTACT
C
Changju Qu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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