Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Официальное название

An Open-label, Single-arm, Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Abexinostat as Monotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Обзор

An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Подробное описание

An open-label, single-arm, multi-center phase 2 study to evaluate the efficacy and safety of oral histone deacetylase (HDAC)-inhibitor abexinostat, as monotherapy in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL)

Вмешательства

• Препарат abexinostat
  abexinostat tablet

Первичные конечные точки

• Clinical effect by evaluating the objective response rate (ORR) [Срок оценки: up to 56 days]

Вторичные конечные точки (2)

• Objective Response [Срок оценки: up to 56 days]
• Progression-free survival [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• Histologically confirmed diffuse large B-cell lymphoma (DLBCL);
• Have received only two prior standard therapy lines for diffuse large B-cell lymphoma (DLBCL) including anti- cluster of differentiation antigen (anti-CD20) antibody and cytotoxic therapy;
• Confirmed to be unresponsive to the last line of therapy, or have disease progression following the last line of therapy;
• Have at least one radiologically measurable lymph node or extranodal lymphoid malignant lesion;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2;
• Meet various hematological, liver and renal function lab parameters.

Критерии исключения

• Have primary central nervous system (CNS) lymphoma or secondary central nervous system (CNS) infiltration, transformed lymphoma, unclassified B-cell lymphoma with features intermediate between DLBCL and classical Hodgkin's lymphoma (HL), primary effusion lymphoma, plasma lymphoma;
• Toxicity not yet recovered from previous anti-tumor therapies;
• Uncontrolled systemic infections or infections requiring intravenous antibiotics;
• Have received steroid hormone, chemotherapy, targeted therapy, radiotherapy, antibody-based therapies, within a specified amount of time per protocol;
• Unable to swallow tablets, or presence of significant functional gastrointestinal disorders that may affect the intake, transport or absorption of the study drug;
• Have received autologous stem cell transplant,or allogeneic stem cell transplant within a certain amount of time as specified in protocol;
• Presence of active graft-versus-host reaction;
• Have undergone a major surgery within the last month;
• Evidence of possible human immunodeficiency virus (HIV) infection or hepatitis C virus (HCV) infection;
• Have any cardiac impairment as defined per protocol;
• Have prior history of malignancies other than diffuse large B-cell lymphoma (DLBCL).

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 · 23 центра

• Cancer Hospital Chinese Academy of Medical Sciences — Пекин
• China-Japan Friendship Hospital — Пекин
• Peking University Third Hospital — Пекин
• West China Hospital, Sichuan University — Чэнду
• The First Affiliate Hospital of Dalian Medical University — Dalian
• Fujian Medical University Union Hospital — Фучжоу
• Fujian Provincial Cancer Hospital — Фучжоу
• Cancer Center of Guangzhou Medical University — Гуанчжоу
• … и ещё 15 центров

Идентификаторы

NCT: NCT03936153 · XYN-606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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