EUCTR2014-001949-25-DE进行中（未招募）1 期
A Phase I/II study of the tumor-targeting human L19IL2 monoclonal antibody-cytokine fusion protein in combination with Rituximab in relapsed or refractory Diffuse Large B-cell Lymphoma (DLBCL)
Philogen S.p.A.0 个研究点目标入组 20 人开始时间: 2014年7月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- 性别
- All
入选标准
- •1.Histologically confirmed CD 20-positive DLBCL
- •2.Patients must have experienced relapse after or did not achieve CR with standard R-CHOP-like treatment and must be ineligible for autologous stem cell transplantation or must have relapsed/progressed after autologous or allogeneic stem cell transplantation
- •3.Presence of measurable lesions according to Revised response criteria for malignant lymphoma
- •4.Males or females, age = 18 years
- •5.ECOG performance status = 2
- •6.Life expectancy of at least 12 weeks
- •7.Absolute neutrophil count > 1.5 x 10^9/L
- •8.Hemoglobin > 8.0 g/dL
- •9.Platelets > 50 x 10^9/L
- •10.Total bilirubin = 30 µmol/L (or = 2.0 mg/dl)
- •11.No abnormal electrocardiogram findings requiring treatment
- •12.ALT and AST = 3.0 x the upper limit of normal (ULN) (5.0 x ULN for patients with hepatic involvement with tumor)
- •13.Serum creatinine < 2 x ULN
- •14.All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v4.03) Grade = 1 unless otherwise specified above
- •15.Negative serum pregnancy test (for women of child-bearing potential only) at screening
- •16.If of childbearing potential, agreement to use adequate contraceptive methods (e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterine contraceptive devices, or sterilization) beginning at the screening visit and continuing until 3 months following last treatment with study drug
- •17.Able to provide written Informed Consent
- •18.Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1.Primary central nervous system lymphoma
- •2.Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis & Ti) or any cancer curatively treated < 5 years prior to study entry
- •3.History of HIV infection or infectious hepatitis B or C
- •4.Presence of active infections (e.g. requiring antimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
- •5.History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
- •6.Inadequately controlled cardiac arrhythmias including atrial fibrillation
- •7.Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
- •8.Uncontrolled hypertension
- •9.Ischemic peripheral vascular disease (Grade IIb-IV)
- •10.Severe diabetic retinopathy
- •11.Active autoimmune disease
- •12.History of organ allograft or stem cell transplantation
- •13.Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment
- •14.Known history of allergy to IL2 or other human proteins/peptides/antibodies
- •15.Positive serum pregnancy test (for women of child-bearing potential only) at screening
- •16.Breast feeding female
- •17.Anti-tumor therapy within 4 weeks of the administration of study treatment (except small surgery)
- •18.Patient requires or is taking corticosteroids or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions is not considered an exclusion criterion
- •19.Any conditions that in the opinion of the investigator could hamper compliance with the study protocol
研究者
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