Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (R/R PTCL)

Официальное название

A Phase II, Open-label, Single-arm, Multicenter Study of Chidamide in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

Обзор

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.

Подробное описание

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. To determine eligibility, subjects must have PTCL confirmed with a sample or specimen evaluated by the investigator.A treatment cycle is defined as 4 weeks. All eligible subjects will be treated with chidamide until disease progression, intolerable toxicity effects, death, or withdrawal of consent.

Вмешательства

• Препарат Chidamide
  Subjects will receive a single dose of 30 mg chidamide. Twice a week.

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: 24 months]

Вторичные конечные точки (10)

• Time to response (TTR) [Срок оценки: 24 months]
• Duration of response (DOR) [Срок оценки: 24 months]
• Progression-free survival (PFS) [Срок оценки: 24 months]
• Overall survival (OS) [Срок оценки: 24 months]
• Pharmacokinetics profiles - (AUC0-t) [Срок оценки: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)]
• Pharmacokinetics profiles - (AUC0-∞) [Срок оценки: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)]
• Pharmacokinetics profiles - (Cmax) [Срок оценки: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)]
• Pharmacokinetics profiles - (Tmax) [Срок оценки: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)]
• Pharmacokinetics profiles - (T1/2) [Срок оценки: Blood samples collected on Days 1-4 and 25-28 of Cycle 1, pre-dose and up to 72 hours post-dose (28 days/cycle)]
• Pharmacokinetics profiles - (Ctrough) [Срок оценки: PK samples collected on Day 15, Day 18, and Day 22 predose (28 days/cycle)]

Критерии участия

Критерии включения

• 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 kinase-positive (ALK+) anaplastic large-cell lymphoma (ALCL), ALK-negative (ALK-) ALCL, angioimmunoblastic T-cell lymphoma (AITL), extranodal natural killer (NK)/T-cell lymphoma, nasal type (ENKL), etc., except cutaneous form or leukemic form.
• 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.

Критерии исключения

• 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 one year, congestive heart failure (CHF), or any other symptomatic coronary artery disease requiring treatment.
• 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), abnormal renal function (serum creatinine >1.5 x ULN), or abnormal complete blood count (absolute neutrophil counts <1500/μL; platelet counts <90 x 1000/μL, hemoglobin <9 g/dL).
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 6 центров

• Chang Gung Memorial Hospital, Kaohsiung — Kaohsiung City
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City
• Far eastern memorial hospital — New Taipei City
• Taichung Veterans General Hospital — Taichung
• National Taiwan University Hospital — Taipei
• Chang Gung Memorial Hospital, Linkou — Taoyuan

Идентификаторы

NCT: NCT05833724 · KEPIDA-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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