A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 23
- 主要终点
- Response Rate (Complete and Partial Response)
研究概览
简要总结
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
Secondary
- Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
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
- •Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination.
- •At least one objective measurable or evaluable disease parameter.
- •Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •Adequate renal function as indicated by creatinine <= 1.5 the upper limit of normal (ULN).
- •Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) <= 2x the upper limit of normal.
- •Total bilirubin <= 2x the upper limit of normal.
- •Age 18 or older.
排除标准
- •Prior cyclosporine or Tacrolimus (FK506).
- •Prior allogeneic transplant.
- •Evidence of active infection.
- •Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities.
- •Evidence of active neurological impairment.
- •Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil).
- •History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin).
- •pregnant or breastfeeding women.
- •Human immunodeficiency virus (HIV) positive.
研究组 & 干预措施
Cyclosporine
High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
干预措施: cyclosporine (Drug)
结局指标
主要结局
Response Rate (Complete and Partial Response)
时间窗: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.
Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of \> 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
次要结局
- Overall Survival(Assessed every 3 months for 2 years, then every 6 months for 1 year.)