Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
- Conditions
- Hairy Cell Leukemia (HCL)
- Registration Number
- NCT02157181
- Lead Sponsor
- Jurgen Barth
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 89
Inclusion Criteria:<br><br> - Patients with histologically verified hairy cell leukaemia (HCL) Hairy cell<br> leukaemia variant (HCLv) or<br><br> - Relapse of hairy cell leukaemia after therapy with cladribine or pentostatin<br><br> - Need for treatment is indicated (see 4.3 below)<br><br> - Age at least 18 years<br><br> - General state of health according to WHO 0-2<br><br> - Written declaration of consent by the patient<br><br> - Current histology, which should not be older than 6 months, is necessary<br><br>Exclusion Criteria:<br><br> - Patients, who do not fulfil the above-mentioned inclusion criteria.<br><br> - Patients with severe functional limitations of the heart according to New York Heart<br> Association III / IV, of the lung according to WHO degree III / IV, the liver<br> (bilirubin > 2mg/dl, alkaline phosphatase, raised GOT and GPT (glutamate- pyruvate<br> transaminase) values more than twice normal), diseases of the central nervous<br> system, including psychoses. Creatinine > 2 mg/dl, or creatinine clearance < 50<br> mg/min<br><br> - Patients with proven HIV infections<br><br> - Patients with active hepatitis<br><br> - Patients with other florid infections<br><br> - Patients with anamnesis / diagnosis of another malignant disease (other than<br> nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix)<br><br> - Pregnant or lactating women
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of complete remissions (CR)
- Secondary Outcome Measures
Name Time Method Overall remission rate (ORR)