NCT06521255招募中3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
- 试验地点
- 20
- 主要终点
- Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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.
研究组 & 干预措施
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Experimental
干预措施: Tafasitamab (Drug)
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Experimental
干预措施: Lenalidomide (Drug)
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Experimental
干预措施: Gemcitabine (Drug)
Tafasitamab and lenalidomide in combination with gemcitabine and oxaliplatin
Experimental
干预措施: Oxaliplatin (Drug)
Rituximab in combination with gemcitabine and oxaliplatin
Active Comparator
干预措施: Gemcitabine (Drug)
Rituximab in combination with gemcitabine and oxaliplatin
Active Comparator
干预措施: Oxaliplatin (Drug)
Rituximab in combination with gemcitabine and oxaliplatin
Active Comparator
干预措施: Rituximab (Drug)
结局指标
主要结局
Dose limiting toxicity（DLT）and other adverse events (AEs) of tafasitamab and lenalidomide in combination with GemOx (TL-GemOx) assessed using CTCAE v5.0
时间窗: within 28 days after therapy initiation
PFS assessed by IRC according to Lugano 2014
时间窗: 1-3 years approximately
次要结局
- Overall Survival (OS)(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)(1-3 years approximately)
- Duration of Response (DOR) according to investigator.(1-3 years approximately)
- Adverse events assessed by CTCAE version 5.0 criteria.(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)(1-3 years approximately)
- Time to response (TTR)(1-3 years approximately)
- Objective Response Rate (ORR) according to investigator.(1-3 years approximately)
- Complete Response Rate (CRR) according to investigator.(1-3 years approximately)
- Progression free survival (PFS) assessed by investigator according to the Lugano 2014(1-3 years approximately)
- Time to next treatment (TTNT)(1-3 years approximately)
研究者
研究点 (20)
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