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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Cladribine s.c. injection, HCL treatment
DrugPatients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Cladribine s.c. injection, HCL treatmentOther 1 intervention
Trial outcomes
Primary outcomes
1
Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
Time frame
4 months after treatmentSecondary outcomes
1
Rate of complete remissions in patient who still have detectable residual disease
A second cycle of cladribine after an interval of 4 months following the first cycle.
Time frame
4 months after treatmentOther outcomes
1
Overall effectiveness
Determination of: * overall remission rate * duration of remission * immunodeficiency induced by treatment, its duration, infectious and other complications resulting from that * frequency of secondary neoplasia during life long follow up * overall survival
Time frame
20 years2
Improvement of remission deepness
Can a complete remission be achieved with a second cycle in patients who have achieved only a partial remission after one cycle?
Time frame
Date of staging after first cycle + 4 months3
Improvement of remission quality
Can the quality of remission achieved with the first cycle be improved with a second cycle?
Time frame
Date of staging after first cycle + 4 months4
Lowering risk of relapse
Can the expected risk of relapse be lowered and the duration of remission be prolonged?
Time frame
Date of proven remission until the date of firdt documented progression or date of death from any cause, whichever came first, assessed up to 20 yearsSponsors and contacts
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Source ClinicalTrials.gov