Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 19
- 主要终点
- Rate of complete remissions (CR)
研究概览
简要总结
The study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (LITAK®) plus anti-CD20* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy.
CD20* = cluster of differentiation antigen 20
详细描述
The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.
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 leukaemia (HCL) Hairy cell leukaemia variant (HCLv) or
- •Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin
- •Need for treatment is indicated (see 4.3 below)
- •Age at least 18 years
- •General state of health according to WHO 0-2
- •Written declaration of consent by the patient
- •Current histology, which should not be older than 6 months, is necessary
排除标准
- •Patients, who do not fulfil the above-mentioned inclusion criteria.
- •Patients with severe functional limitations of the heart according to New York Heart Association III / IV, of the lung according to WHO degree III / IV, the liver (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50 mg/min
- •Patients with proven HIV infections
- •Patients with active hepatitis
- •Patients with other florid infections
- •Patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)
- •Pregnant or lactating women
研究组 & 干预措施
HCL, 2CdA +/- Rituximab
Risk stratification
- HCL variant will be treated with cladribine plus rituximab, independent of previous therapy
- Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is < 3 years.
- All repeated relapses (> 1st relapse) after previous therapies with purine analogues and/or interferon will be treated with cladribine plus rituximab.
Cladribine (LITAK®) 0.14 mg/kg daily Days 8-12 subcutaneous bolus injection Rituximab (Mabthera®) 375 mg/m2 daily Days 1, 8, 15, 22 infusion 4. Relapses of HCL will be treated with cladribine monotherapy, if the duration of remission of the previous therapy is > 3 years.
Cladribine (LITAK®) 0.14 mg/kg daily Days 1-5 subcutaneous bolus injection
干预措施: 2CdA +/- Rituximab (Drug)
结局指标
主要结局
Rate of complete remissions (CR)
时间窗: 4 months after treatment
Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab * in patients with hairy cell leukaemia variant * in patients with relapsed hairy cell leukaemia
次要结局
- Overall remission rate (ORR)(4 months after treatment)
研究者
Jurgen Barth
Professor Dr. med Mathias Rummel
University of Giessen