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New treatment option for Relapsed/Refractory Peripheral T Cell Lymphoma
Official title A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
ClinicalTrials.gov ID: NCT06776952
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Aged 18-70 years (inclusive)，gender not limited.
- Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.
- Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors...
- people who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.
- Having at least one measurable lesion for evaluation.
You likely can't join if
- Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s).
- Prior exposure to HDAC inhibitor(s).
- people with known hypersensitivity to the study drug or its active ingredients or excipients.
- people who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives...
- people who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study.
- people who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study...
See the full eligibility criteria
Who can join
- Aged 18-70 years (inclusive)，gender not limited.
- Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma.
- Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, people with NK/T-cell lymphoma require treatment with a regimen...
- people who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy.
- Having at least one measurable lesion for evaluation.
- Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements.
- Life expectancy of at least 12 weeks.
- people must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Have adequate organ function.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is...
- Able to provide written informed consent form prior to the commencement of any study activity/procedure.
What rules you out
- Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s).
- Prior exposure to HDAC inhibitor(s).
- people with known hypersensitivity to the study drug or its active ingredients or excipients.
- people who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug...
- people who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study.
- people who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy).
- people who have an allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- people who have received systemic treatment with corticosteroids (prednisone at a dose of \> 10 mg per day or equivalent doses of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the use...
- people taking known strong CYP3A4 inhibitors/inducers and P-glycoprotein (P-gp) inhibitors within 14 days prior to the first dose.
- people who have received live virus vaccines (including live attenuated vaccines) within 28 days prior to dosing. Inactivated vaccines are permitted.
- people with a history of psychotropic drug abuse or drug abuse.
- people who have received anti-tumor therapy in the early stage and have not recovered from toxicity (toxicity has not recovered to ≤ Grade 1 according to NCI-CTCAE 5.0). Except for other toxicities (such as alopecia...
- people with history of other malignancies within 3 years prior to enrollment and not meeting clinical cure criteria. Exceptions are the following: cured basal cell or squamous cell carcinoma of the skin, superficial...
- people with mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma.
- people with previous or current central nervous system invasion.
- people with previous or current testicular or breast invasion.
- people with previous or current hemophagocytic syndrome.
- people with previous or current primary or secondary hematologic diseases that may affect bone marrow function in addition to primary malignancies, such as immune thrombocytopenia, autoimmune hemolytic anemia, aplastic...
- people with previous or current acute myeloid leukemia (AML).
- people with previous or current T-cell lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia.
- people who have any history of myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal tests results of markers related to MDS or myeloproliferative neoplasm (MPN).
- people who previously hadcentral nervous system lesions, or diseases accompanies with central nervous system lesions, including but not limited to, epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease...
- people with clinically significant cardiovascular disease.
- Tumor invasion of important peripheral organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) posing a risk of bleeding or the risk of esophageal tracheal fistula...
- people with clinically symptomatic thoracoabdominal effusion or pericardial effusion that are poorly controlled after repeated treatment.
- people with unexplained fever and body temperature\>38.0 ℃.
- people who have severe active systemic infection.
- people with a history of tuberculosis infection within one year prior to enrollment, or with a history of active tuberculosis infection more than one year ago without sufficient anti tuberculosis treatment.
- A known history of HIV infection or acquired immunodeficiency syndrome (AIDS), or Anti- Treponema Pallidum test (anti-TP) positive.
- people who have HBV-DNA copy numbers higher than the lower normal limit of the detection value. people with HCV-RNA copy number higher than the lower normal limit of the detection value.
- people who are unable to swallow or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or has undergone gastrectomy or gastric banding that affects drug absorption. But...
- people with conditions known to have bleeding tendencies, such as von Willebrand disease or hemophilia.
- people who are pregnant or breastfeeding, or expects to conceive within the projected duration of the study.
- Subject who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not participate the study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 days to 70 days. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.