EUCTR2017-003149-56-DE进行中（未招募）1 期
OBINUTUZUMAB in MARGINAL ZONE LYMPHOMA
niversity Hospital Ulm0 个研究点目标入组 56 人开始时间: 2018年1月10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
- 56
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
- •Patients must have a proven pathological diagnosis of MZoL, diagnosed by a reference pathology center.
- •Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Confirmed CD20 positive de novo MALT Lymphoma following or being not eligible for local therapy (including surgery, radiotherapy) and antibiotics e.g. for H. pylori-positive gastric lymphoma arisen at any extranodal site
- •ORConfirmed CD20 positive de novo splenic MZoL following or not being eligible for local therapy (including surgery and antiviral therapy for Hepatitis C Virus) with symptomatic disease
- •OR Confirmed CD20 positive de novo nodal MZoL following or not being eligible for local therapy (radiotherapy)
- •For patients with symptomatic splenic, nodal, or non-gastric extranodal MZoL disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator.
- •For patients with symptomatic gastric extranodal MZoL: Helicobacter pylori-negative disease that is de novo or has relapsed following local therapy (i.e., surgery or radiotherapy) and requires therapy, as assessed by the investigator, or H. pylori–positive disease that has remained stable, progressed, or relapsed following antibiotic therapy and requires therapy, as assessed by the investigator
- •–At least one bi-dimensionally measurable lesion (= 1.5 cm in its largest dimension by CT scan or MRI).
- •For an enlarged liver to constitute the only measurable disease parameter, a liver biopsy showing proof of NHL in the liver is required.
- •In patients with splenic MZoL, an enlarged spleen on CT scan or extending at least 2 cm below the costal margin by physical examination will constitute measurable disease providing that no explanation other than lymphomatous involvement is likely.
- •At least one of the following must be met:
- •–Bulky progressive or painful splenomegaly
- •–one of the following symptomatic/progressive cytopenias : Hb < 10 g/dL, or Plat < 80.000 /µL, or neutropenia < 1000 /µL, whatever the reason (autoimmune or hypersplenism or bone marrow infiltration)
- •–enlarged lymphoadenopathy or involvement of extranodal sites with or without cytopenia
- •–splenectomised patients with rapidly raising lymphocyte counts, development of lymphadenopathy or involvement of extranodal sites
- •–SMZL with concomitant hepatitis C infection who have not responded to or are relapsed after Interferon and/or Ribavirin (patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- •For gastric MALT Lymphoma:
- •–H. pylori-negative disease de novo or following or being not eligible for local therapy (i.e., surgery, radiotherapy or antibiotics).
- •–H. pylori–positive disease that has remained stable, progressed, or relapsed following antibiotic therapy.
- •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 16
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •–ECOG performance status >2
- •–History of a non-lymphoid malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy or requiring only hormonal therapy and with normal prostate specific antigen for =1 year prior to study enrollment visit, other Stage 1 or 2 cancer treated with a curative intent and currently in complete remission, for =3 years.
- •–Central nervous system lymphoma, leptomeningeal lymphoma, or histologic evidence of transformation to a high-grade or diffuse large B-cell lymphoma.
- •–Ongoing immunosuppressive therapy including corticosteroids (exception < 4 weeks administered at a dose equivalent to <=40 mg/day prednisone is allowed)
- •–Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of study enrollment visit
- •–Ongoing drug-induced liver injury, chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
- •–Ongoing alcohol or drug addiction
- •–Breastfeeding or pregnancy
- •–Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram (ECG) finding, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results.
- •–History of anaphylaxis in association with previous administration of monoclonal antibodies.
- •–Vaccination with a live vaccine within 28 days prior to start of therapy
- •–Treatment with any other investigational agent within 30 days or within 5 x the half-life (t1/2) of the investigational product, whichever is longer, or participating in another trial within 30 days prior to entering this study.
研究者
相似试验
进行中（未招募）
2 期
Obinutuzumab in Marginal Zone LymphomaMarginal Zone LymphomaNCT03322865Christian Buske56
进行中（未招募）
不适用
INTRAVITREAL RANIBIZUMAB THERAPY FOR MACULA EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCLUSION (RAVO) - RAVOEUCTR2006-005450-71-DEAugenklinik der LMU München60
进行中（未招募）
1 期
Efficacy of pembrolizumab in patients with marginal zone lymphomaMarginal Zone LymphomaMedDRA version: 20.0Level: PTClassification code 10076596Term: Marginal zone lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-000187-28-DEniversity Hospital Ulm56
进行中（未招募）
1 期
Efficacy of pembrolizumab in patients with marginal zone lymphomaEUCTR2018-000187-28-ATniversitätsklinikum Ulm56
进行中（未招募）
1 期
EVALUATION OF EFFICACY AND SAFETY OF OBINUTUZUMAB PREEMPTIVE TREATMENT AT THE TIME OF THE MOLECULAR RELAPSE AFTER FIRST LINE IMMUNOCHEMOTHERAPY WITH AUTOLOGOUS STEM CELL TRANSPLANTATION IN MANTLE CELL LYMPHOMA PATIENTS. OPERA PLRG-10 TRIAL (ML29157)EUCTR2015-005439-41-PLPolish Lymphoma Research Group (PLRG)60