Phase I/II Study of Alemtuzumab (CAMPATH 1H) Associated to G-CSF in Adult Patients With Refractory Acute Lymphocytic Leukemia (ALL) or ALL in Relapse.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Partial and complete remission, overall response rates
研究概览
简要总结
Alemtuzumab is an anti CD52 monoclonal antibody. The CD52 antigen is present at the surface of B,T NK lymphocytes. It is expressed at various levels at the surface of ALL blast cells. Adult patients with ALL in relapse have less than 10% probability of long term survival. The present study will test the response rate (partial and complete remission) of refractory ALL or ALL in relapse. It is hoped that if a CR can be achieved, further consideration will be given for a hematopoietic stem cell transplant.
The use of G-CSF is justified by a possible increase in ADCC.
详细描述
All patients receive Alemtuzumab in 3 successive phases:
Phase A: Test week: 3mg, then 10mg, then 30mg every other day for one week to test for tolerance.
Phase B: 30mg 3 times a week for 12 to 18 administrations until response or progression/failure has been documented.
Phase C: in patients in CR, maintenance with Alemtuzumab: 3 injections one week every 2 months.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 15 years
- •Refractory ALL
- •ALL in relapse post chemotherapy or post transplant
- •ALL blast cells expressing CD 52 antigen at any time during the evolution of the disease.
- •Signed informed consent
- •Patients under social security coverage
- •Anti conceptional tablets in pre menopausal women.
排除标准
- •Children below 15 years of age or aged 15
- •Blast cells not expressing CD52 antigen (at all evaluations)
- •HIV positivity
- •ECOG Score 3 and 4
- •Hypersensitivity to Alemtuzumab.
- •Pregnancy or breast feeding.
- •Other malignant disease in addition to ALL.
研究组 & 干预措施
1
all included patients
干预措施: Alemtuzumab (CAMPATH 1H) associated to G-CSF (Drug)
结局指标
主要结局
Partial and complete remission, overall response rates
时间窗: At 2 years
次要结局
- Valuation of tolerance, more particularly targeted at the immunodeficiency shortage, contagious complications and neurotoxicity assessed according to the NCI (National Cancer Institute) classification.(At 2 years)
- Valuation of the response waiting time, from the first day of the induction treatment to the REEVOLUTING.(at 2 years)