Therapy Optimisation for the Treatment of Hairy Cell Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 28
- 主要终点
- Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
研究概览
简要总结
The trial will test the effectiveness and toxicity of subcutaneous treatment with one cycle of cladribine in patients with hairy cell leukemia requiring treatment.
They have to be untreated so far or may be pretreated with alpha-interferon.
详细描述
Evaluation of remission status will take place 4 months after treatment. In addition, it will be tested whether patients with non-optimal response will have a benefit from a second cycle of cladribine.
Non-optimal response is: patients with detectable residual disease; achievement of partial remission or detectable residual infiltration in the bone marrow.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically verified hairy cell leukemia
- •Presence of hairy cells in the bone marrow and peripheral blood detected by positive TRAP staining and / or co expression if cell surface antigens cluster of differentiation (CD) 19/CD25 or CD19/CD103 (b-ly7)
- •No previous cytostatic treatment (splenectomy or interferon treatment are allowed)
- •Need for treatment
- •Age at least 18 years old
- •General state of health according to WHO 0-2
- •Current histology, not older than 6 months
- •Written consent by patient
排除标准
- •Patients not fulfilling inclusion criteria above
- •Hairy cell leukemia variants (HCL-V): presence of lymphoid cells in bone marrow and / or peripheral blood, which have an intermediate morphology between hairy cells and prolymphocytes (negative TRAP staining and co- expression of CD19/CD103 without CD25
- •Pretreatment with purine analogues or other chemotherapeutics
- •Concomitant corticosteroid therapy
- •Severe dysfunction of the heart (NYHA III or IV), the lung (WHO-Grade III or IV), the liver, except due to lymphoma (bilirubin > 2 mg/dl, alkaline phosphatase, glutamate-oxalacetate transaminase and glutamate-pyruvate transaminase > 2 x upper limit of normal), the kidneys (creatinin > 2 mg/dl or creatinine clearance < 50 ml/min), central nervous system diseases including psychoses.
- •Proven HIV infection
- •Active Hepatitis
- •Other florid infections
- •Anamnesis / diagnosis of other malignant disease (other than non-melanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
- •Pregnant or lactating women
研究组 & 干预措施
Cladribine s.c. injection, HCL treatment
Cladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment
干预措施: Cladribine s.c. injection, HCL treatment (Drug)
结局指标
主要结局
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
时间窗: 4 months after treatment
次要结局
- Rate of complete remissions in patient who still have detectable residual disease(4 months after treatment)
研究者
Jurgen Barth
Head of StiL Coordinating Center
University of Giessen