EUCTR2018-001127-40-ES进行中（未招募）1 期
A PHASE I/II TRIAL OF MOSUNETUZUMAB (BTCT4465A) AS CONSOLIDATION THERAPY IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA FOLLOWING FIRST-LINE IMMUNOCHEMOTHERAPY AND AS THERAPY IN PATIENTS WITH PREVIOUSLY UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA WHO ARE UNABLE TO TOLERATE FULL-DOSE CHEMOTHERAPY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion Criteria for All Cohorts
- •-Age >= 18 years
- •- At least one bi-dimensionally measurable nodal lesion
- •- Life expectancy of at least 24 weeks
- •- Adequate hematologic function
- •- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- •-Use of contraception as defined by the protocol
- •Inclusion criteria specific to Cohort A
- •- Histologically confirmed DLBCL according to WHO 2016 classification
- •- One prior systemic chemotherapy containing regimen for DLBCL
- •- Best response of PR to prior systemic chemotherapy
- •- Age >= 18 years
- •- Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition /echocardiogram scan within the institutional limits of normal
- •-- Use of contraception as defined by the protocol
- •Inclusion criteria specific to Cohort B
- •- Previously untreated, histologically confirmed, DLBCL according to WHO 2016
- •- - In the opinion of the investigator, unable to receive full-dose standard
- •chemotherapy
- •- Age greater than or equal 80 years or 60 to 79 years, as defined below:
- •-The patient must have adequate end-organ function
- •-For patients who are 60 to 79 years of age, at least one of the
- •- Impairment in at least one activity of daily living or instrumental
- •activity of daily living
- •- Impairment in cardiac function, renal function, or liver function such
- •that the patient is unable to tolerate full-dose immunochemotherapy,
- •such as R-CHOP
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Exclusion Criteria for All Cohorts
- •- Transformed lymphoma
- •- Prior treatment with mosunetuzumab
- •- Prior stem cell transplant (autologous and allogeneic)
- •- Administration of a live, attenuated vaccine within 4 during a specified period
- •- Prior solid organ transplantation
- •- History of autoimmune disease
- •- Received systemic immunosuppressive medications
- •- Current or past history of central nervous system (CNS) disease
- •- History of other malignancy
- •- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol
- •- Known active bacterial, viral, fungal or other infection at study enrollment
- •- Clinically significant history of liver disease
- •- Recent major surgery within a specified period
- •- Abnormal laboratory values
- •- Prior treatment with radiotherapy
- •- Adverse events from prior anti-cancer therapy not resolved to <= Grade 1
- •- Significant cardiovascular disease or significant pulmonary disease
- •Exclusion Criteria Specific to Cohort A
- •- Prior treatment with chemotherapy, immunotherapy, or biologic therapy within a specified period
- •- Pregnant or breastfeeding, or intending to become pregnant during the study
- •Exclusion Criterion Specific to Cohort B
- •- Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy
研究者
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