Therapy Optimisation for the Treatment of Hairy Cell Leukemia
ConditionHairy Cell Leukemia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Giessen
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cladribine s.c. injection, HCL treatment
Treatment groups
210 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov