Actively Recruiting
A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Led by Evopoint Biosciences Inc. · Updated on 2026-01-09
120
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.
CONDITIONS
Official Title
A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18-70 years inclusive, any gender
- Pathologically diagnosed with relapsed or refractory peripheral T-cell lymphoma
- Relapsed or refractory after at least one prior systemic treatment line and no prior HDAC inhibitor treatment
- For NK/T-cell lymphoma, prior treatment with asparaginase/protease regimen required
- For CD30 positive ALCL, prior treatment with Brentuximab vedotin required
- Prior radiotherapy allowed but not considered systemic therapy alone
- At least one measurable lesion for evaluation
- Agree to provide archived or fresh tumor tissue samples
- Life expectancy of at least 12 weeks
- ECOG performance status of 0 or 1
- Adequate organ function
- Females of childbearing potential must have a negative pregnancy test within 7 days before first dose
- Non-sterile subjects must agree to use effective contraception during study and 6 months after last dose
- Males with female partners of childbearing potential must agree to use effective contraception and not donate sperm during study and 6 months after last dose
- Able to provide written informed consent prior to study procedures
You will not qualify if you...
- Prior exposure to EZH2 or EZH1/2 inhibitors
- Prior exposure to HDAC inhibitors
- Known hypersensitivity to study drugs or ingredients
- Received anti-tumor therapy within 4 weeks or 5 half-lives before first study dose
- Received CAR-T therapy within 12 weeks before first study dose
- Autologous hematopoietic stem cell transplantation within 3 months before first study dose
- Received other investigational anti-tumor drugs within 28 days before first dose
- Major surgery within 4 weeks before study start or planned during study (except minor procedures)
- Allogeneic hematopoietic stem cell or solid organ transplantation
- Systemic corticosteroids (>10 mg prednisone or equivalent) or immunosuppressives within 14 days before study drug, except inhaled/topical steroids or low-dose adrenal replacement
- Use of strong CYP3A4 or P-glycoprotein inhibitors/inducers within 14 days before first dose
- Live virus vaccines within 28 days before dosing; inactivated vaccines allowed
- History of psychotropic drug abuse
- Unrecovered toxicity from prior anti-tumor therapy except alopecia or non-safety affecting toxicities
- Other malignancies within 3 years except certain cured localized cancers
- Mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma
- Previous or current central nervous system or testicular/breast invasion
- Hemophagocytic syndrome
- Primary or secondary hematologic diseases affecting bone marrow function besides primary malignancies
- Previous or current acute myeloid leukemia or T-lymphoblastic lymphoma/leukemia
- History of myeloid malignancy including MDS or abnormal related markers
- History of central nervous system lesions or diseases causing neurological issues
- Clinically significant cardiovascular disease
- Tumor invasion of critical organs or vessels posing bleeding or fistula risk
- Poorly controlled thoracoabdominal or pericardial effusion
- Unexplained fever above 38.0°C
- Severe active systemic infection
- Tuberculosis infection within one year or untreated active tuberculosis history
- Known HIV/AIDS or positive Anti-Treponema Pallidum test
- HBV or HCV viral load above detection limits
- Unable to swallow or history of gastrointestinal conditions affecting drug absorption
- Conditions causing bleeding tendencies
- Pregnant or breastfeeding or planning conception during study
- Any other condition or reason judged by investigator to prevent study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
Y
Yuqin Song
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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