Overview

Therapy Optimisation for the Treatment of Hairy Cell Leukemia

Status:
Recruiting
Trial end date:
2027-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Giessen
Treatments:
Cladribine
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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