NCT05552937招募中2 期
A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Tafasitamab Combined with Lenalidomide in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age >18 years.
- •Histologically confirmed diagnosis of DLBCL not otherwise specified (NOS); T cell/histiocyte rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus (EBV) positive DLBCL of the elderly (EBV-positive DLBCL), Grade 3b Follicular Lymphoma, Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse, according to the Revised European American Lymphoma/World Health Organization (REAL/WHO) classification. Additionally, patients with the evidence of histological transformation to DLBCL from an earlier diagnosis of low grade lymphoma (i.e., an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukaemia) into DLBCL with a subsequent DLBCL relapse are also eligible.
- •Patients received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy.
- •Patients must meet the following laboratory criteria at screening.
- •Patients must use an effective barrier method of contraception.
- •In the opinion of the investigator the patients must be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events; be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
排除标准
- •Patients who have other histological type of lymphoma，primary refractory DLBCL，a history of "double/triple hit" genetics.
- •Patients who have, within 14 days prior to Day 1 dosing:
- •not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy.
- •undergone major surgery or suffered from significant traumatic injury.
- •received live vaccines.
- •required parenteral antimicrobial therapy for active, intercurrent infections.
- •Patients who:
- •were previously treated with CD19-targeted therapy or IMiDs® (e.g. thalidomide, LEN).
- •have undergone ASCT within the period ≤ 3 months prior to signing the informed consent form.
- •have undergone previous allogenic stem cell transplantation.
- •have a history of deep venous thrombosis/embolism and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
- •concurrently use other anticancer or experimental treatments.
- •Prior history of malignancies other than DLBCL.
- •Patients with:
- •positive hepatitis B and/or C serology.
- •known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV).
- •CNS lymphoma involvement.
- •history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromise the patient's ability to give informed consent.
- •history or evidence of severe hepatic impairment (total serum bilirubin > 3 mg/dL).
研究组 & 干预措施
Tafasitamab and Lenalidomide
Experimental
Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.
干预措施: Tafasitamab and Lenalidomide (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 1-3 years approximately
Evaluation by the Independent Review Committee (IRC).
次要结局
- Time to maximum serum concentration (tmax)(2 years)
- Objective Response Rate (ORR)(1-3 years approximately)
- Duration of Response (DOR)(1-3 years approximately)
- Progression Free Survial (PFS)(1-3 years approximately)
- Disease Control Rate (DCR)(1-3 years approximately)
- Potential immunogenicity of Tafasitamab.(2 years)
- Maximum serum concentration (Cmax)(2 years)
- Overall Survival (OS)(1-3 years approximately)
- Safety of Lenalidomide combined with Tafasitamab according to the frequency and severity of adverse events (AEs).(2 years)
- Apparent trough serum concentration before dosing (Cpd)(2 years)
- Time to progression (TTP)(1-3 years approximately)
- Time to response (TTR)(1-3 years approximately)
- Area under the serum concentration versus time curve from time 0 to the time t of the last quantifiable concentration (AUC0-t)(2 years)
研究者
研究点 (1)
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