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New treatment option for Relapsed or Refractory Peripheral T-cell Lymphoma
Official title Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)
ClinicalTrials.gov ID: NCT05833724
What this study is testing
What is Chidamide?
Chidamide is an investigational medicine, being studied as a potential treatment for relapsed or refractory peripheral t-cell lymphoma.
Also referred to as Tucidinostat, HBI-8000.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II, open-label, non-randomized, single-arm, multicenter study to evaluate the efficacy, safety, and PK of chidamide in patients with R/R PTCL.
- Phase 2: a mid-size study of how well it works
- 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 20 to 75
You may be able to join if
- Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included...
- Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
- Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target...
- Male or female, aged 20-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
You likely can't join if
- Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
- Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to...
- Have been treated with histone deacetylase (HDAC) inhibitor.
- With a history of clinically significant QTc prolongation (\>450 ms for males or \>470 ms for females), ventricular tachycardia (VT), atrial...
- The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.
- With a history of organ transplantation.
See the full eligibility criteria
- Histopathological diagnosis, made by the investigator, of the following PTCL subtypes as defined by the WHO classification (2016) may be included: PTCL, not otherwise specified (PTCL-NOS), anaplastic lymphoma...
- Patients for whom at least one measurable lesion according to Cheson Criteria 2014 at baseline.
- Relapsed or refractory disease (including DOR shorter than 30 days) to ≥1 prior systemic therapy including, but not limited to, chemotherapy, target therapy, immunotherapy, and autologous stem cell transplantation.
- Male or female, aged 20-75 years (inclusive).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- With a life expectancy of ≥12 weeks.
- Have not received radiotherapy, chemotherapy, immunotherapy (except for antibody therapy), or target therapy within 4 weeks prior to the start of study drug.
- Have not received any antibody therapy within 12 weeks prior to the start of study drug.
- Willing to provide written informed consent.
- Females who are pregnant or breastfeeding, or females of childbearing potential who are not willing to use adequate contraception.
- Patients in whom central nervous system lymphoma is recognized during screening (if suspected clinically, imaging study should be performed to confirm).
- Have been treated with histone deacetylase (HDAC) inhibitor.
- With a history of clinically significant QTc prolongation (\>450 ms for males or \>470 ms for females), ventricular tachycardia (VT), atrial fibrillation (AF), heart block (HB), myocardial infarction (MI) onset within...
- The size of fluid area detected by cardiac ultrasonography in cavum pericardium is ≥10 mm during diastolic period.
- With a history of organ transplantation.
- With a history of allogeneic stem cell transplantation.
- Have received autologous stem cell transplantation within 12 weeks prior to the start of study drug.
- Have participated in a clinical trial involving investigational antibody therapy within 12 weeks prior to the start of study drug or non-antibody therapy within 4 weeks prior to the start of study drug.
- Have received symptomatic treatment for early myelotoxicity within 7 days prior to the start of study drug.
- With active bleeding or newly diagnosed thromboembolic disease, or with hemorrhagic tendency who are using anticoagulants.
- With active infection of hepatitis B or C, or persistent fever within 14 days prior to the start of study drug.
- With history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome.
- Had a major organ surgery within 6 weeks prior to the start of study drug.
- With abnormal hepatic function (serum total bilirubin \>1.5 x upper limit of normal [ULN]; alanine aminotransferase [ALT]/aspartate aminotransferase [AST] \>2.5 x ULN or \>5 x ULN if liver metastases are present)...
- Has known psychiatric disorders or substance abuse disorders that may interfere with the patient's participation in the study or evaluation of the study results.
- Considered by the investigator as being not suitable to participate the study.
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- New Taipei City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
- Taoyuan, Taiwan
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, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; New Taipei City, Taiwan; Taichung, Taiwan; Taipei, Taiwan; Taoyuan, Taiwan. 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.