Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory/Relapsed Peripheral T-cell Lymphoma

Официальное название

Pralatrexate Combined With Chidamide Bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma

Обзор

This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma

Вмешательства

• Другое Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation
  Drug: Pralatrexate, Chidamide 1. Pralatrexate: 30 mg/m2 intravenously (IV) administered weekly in 6-week cycles. Chidamide: 20mg, twice a week in 3-week cycles (2 weeks on treatment, 1 week off treatment) 2. After the 6-week therapy, the patients should receive PET/CT evaluation. 3. Patients would receive allo-HSCT if they could achieve at least PR after the first cycle of therapy. For the patients could not achieve a least PR after the first cycle of therapy, they should receive a second cycle

Первичные конечные точки

• Progression-free survival (PFS) at 1 year after transplantation [Срок оценки: Participants will be followed for an expected average of 1 years after transplantation]

Критерии участия

Критерии включения

• Patients fully understand the study, voluntarily participate in and sign on the informed consent;
• Diagnosed by histopathology Peripheral T-cell lymphoma;
• ECOG PS score 0 or 1;
• Relapsed or Refractory Peripheral T Cell Lymphoma；
• According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter>1.5cm; measurable extranodal lesion diameter>1.0cm)；
• Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory;
• Expected survival at least 12 weeks；
• Agreed to receive treatment with Pralatrexate

Критерии исключения

• NK/T-cell lymphoma;
• Achieving CR or PR after induction chemotherapies without relapse;
• Dysfunction of vital organs;
• Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
• Unwilling to accept allogeneic hematopoietic stem cell transplantation;
• Undergoing other clinical studies within a month;
• Without donor for transplantation;
• Allergies to similar drugs and excipients of the research drug

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

Китай · 1 центр

• Peking University, Institute of Hematolgoy, Beijing, — Пекин

Идентификаторы

NCT: NCT06671717 · PUPH-PTCL-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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