An Open Label Study of the Effect of Rituxan, High Dose Methotrexate and High Dose Cytarabine on Response Rate in Patients With Primary Central Nervous System Lymphoma.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 主要终点
- Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
研究概览
简要总结
This study will evaluate the efficacy and safety of MabThera plus high dose methotrexate plus high dose cytarabine in patients with central nervous system non-Hodgkin's lymphoma. Eligible patients will receive a treatment regimen consisting of MabThera (750mg/m2 iv) plus methotrexate (8g/m2 iv) given at intervals up to week 22, plus cytarabine (2g/m2 iv) at week 11 and week 22. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients, 18-80 years of age;
- •histological diagnosis of primary central nervous system lymphoma;
- •B-cell proliferation verified by positive staining for CD20;
- •>=1 measurable lesion.
排除标准
- •prior chemotherapy, other than corticosteroids, >=6 weeks before and after diagnosis or surgery;
- •history of prior cranial irradiation;
- •evidence of plurisystemic non-Hodgkin's lymphoma;
- •other active malignant disease (other than basal cell or squamous cell cancer of skin,or cancer in situ of cervix;
- •uncontrolled active infection.
研究组 & 干预措施
1
干预措施: rituximab [MabThera/Rituxan] (Drug)
1
干预措施: Methotrexate (Drug)
1
干预措施: Cytarabine (Drug)
结局指标
主要结局
Percentage of Participants With a Complete Response (CR) or Unconfirmed CR (CRu)
时间窗: Week 24
CR: complete disappearance of all enhancing abnormalities on contrast-enhanced cranial magnetic resonance imaging (MRI); no evidence of active ocular lymphoma as defined by absence of cells in the vitreous and resolution of any previously documented retinal or optic nerve infiltrates; negative cerebrospinal fluid (CSF) cytology; at the time of CR determination, participant had discontinued use of all corticosteroids for at least 2 weeks. CRu requires fulfillment of CR criteria but with these limitations: Fulfills CR criteria but had continued requirement for corticosteroid therapy at any dose; small but persistent enhancing abnormality on MRI related to biopsy or focal hemorrhage; persistent minor abnormality on follow-up ophthalmologic exam (related to persistent non-malignant cells in vitreous, or alterations in retina/optic nerve not consistent with tumor infiltration) if the abnormality is unlikely to represent ocular lymphoma.
Percentage of Participants With a CR, CRu or Partial Response (PR)
时间窗: Week 24
PR: greater than or equal to (≥) 50 percent (%) decrease in the contrast-enhancing lesion seen on MRI as compared with the baseline images; (2) Corticosteroid dose was irrelevant to the determination of PR; for participants with ocular disease, ophthalmologic exam must show a decrease in vitreous cell count or retina/optic nerve cellular infiltrate but may have continued to show persistent malignant or suspicious cells; for participants with CSF positive for neoplastic cells, CSF cytology may be negative or continue to show persistent malignant or suspicious cells in patients with ≥50% decrease in the primary brain lesions; no new sites of disease.
次要结局
- Overall Survival(Time of last follow-up assessment between Day 1 and 3 years)
- Percentage of Participants With Initial CR or CRu and Subsequent Disease Relapse(Week 24)
- Progression-Free Survival (PFS)(Week 24)