Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Официальное название

A Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Обзор

This is a Randomized, Multi-center, Phase 3 Study of Tafasitamab and Lenalidomide in Combination with Gemcitabine and Oxaliplatin versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphom

Вмешательства

• Препарат Tafasitamab
  Tafasitmab was infused intravenously
• Препарат Lenalidomide
  Lenalidomide orally
• Препарат Gemcitabine
  Gemcitabine was infused intravenously
• Препарат Oxaliplatin
  Oxaliplatin was infused intravenously
• Препарат Rituximab
  Rituximab was infused intravenously.

Первичные конечные точки

• Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0 [Срок оценки: within 28 days after therapy initiation]
• PFS assessed by IRC according to Lugano 2014 [Срок оценки: 1-3 years approximately]

Вторичные конечные точки (10)

• Objective Response Rate (ORR) according to investigator. [Срок оценки: 1-3 years approximately]
• Complete Response Rate (CRR) according to investigator. [Срок оценки: 1-3 years approximately]
• Duration of Response (DOR) according to investigator. [Срок оценки: 1-3 years approximately]
• Progression free survival (PFS) assessed by investigator according to the Lugano 2014 [Срок оценки: 1-3 years approximately]
• Time to response (TTR) [Срок оценки: 1-3 years approximately]
• Overall Survival (OS) [Срок оценки: 1-3 years approximately]
• Time to next treatment (TTNT) [Срок оценки: 1-3 years approximately]
• Adverse events assessed by CTCAE version 5.0 criteria. [Срок оценки: 1-3 years approximately]
• Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) [Срок оценки: 1-3 years approximately]
• Quality of life assessment: Patient-reported outcomes (PROs) on happiness and general health status based on EuroQol five dimensions questionnaire (EQ-5D-5L) [Срок оценки: 1-3 years approximately]

Критерии участия

Критерии включения

• 18 Years and older.
• One of the histologies of DLBCL confirmed by participated sites below with，not otherwise specified;T-cell/histiocyte-rich large B-cell lymphoma;Epstein-Barr virus (EBV) positive DLBCL (EBV-positive DLBCL); Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse; Disease transformed from an earlier diagnosis of low-grade lymphoma into DLBCL with DLBCL treatment failure.
• Availability of tumor tissue biopsied post last line of therapy and prior to current study treatment for the patients enrolled in safety and tolerability stage.
• Relapsed/refractory (R/R) DLBCL, at least one (≥1) but no more than three (≤3) line of prior systemic therapies.
• Patients who have not received high dose therapy/stem cell transplantation (HDT/SCT) must be ineligible for HDT/SCT.
• At least one measurable site of disease per CT or magnetic resonance imaging (the longest axis of the lymph node lesion is > 1.5 cm, and the longest diameter of the extra-nodal lesion is > 1.0 cm).
• ECOG PS score of 0 to 2.
• Subject must have adequate organ functions, and the laboratory values comply with the protocol requirements.
• Life expectancy of ≥ 3 months.
• Informed consent before screening and can understand and comply with the requirements of the study.

Критерии исключения

• Existing or prior history of other malignant tumor within 3 years, except for those who have received curative treatment.
• Current or history of central nervous system (CNS) lymphoma.
• Known high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements.
• Primary mediastinal B-cell lymphoma.
• History of allogeneic stem-cell transplantation.
• Prior exposure to anti-CD19 treatment, and (or) failed with gemcitabine plus platinum-based agent combination therapy.
• Current toxicity of ≥ Grade 2 from prior anti-cancer therapy (except for alopecia, neutrophil, hemoglobin and platelets).
• Clinically significant cardiovascular disease or nervous system disease.
• History of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at a high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
• Uncontrolled systemic infection requiring parenteral intravenous anti-infective therapy.
• Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B or C infection.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 20 центров

• Beijing Hospital — Пекин
• The First Hospital Of Jilin University — Changchun
• Hunan Cancer Hospital — Чанша
• Chenzhou No.1 People's Hospital — Chaozhou
• Sichuan Province People's Hospital — Чэнду
• The First Affiliated Hospital of Chongqing Medical University — Чунцин
• Guangdong General Hospital — Гуанчжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• … и ещё 12 центров

Идентификаторы

NCT: NCT06521255 · ICP-CL-00903

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗