Overview

Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Jurgen Barth
Treatments:
2-chloro-3'-deoxyadenosine
Cladribine
Rituximab
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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