Clinical trial · Interventional
Therapy Optimisation for the Treatment of Hairy Cell Leukemia
NCT02131753CI-TRIAL-00080089recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hairy Cell Leukemia | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cladribine s.c. injection, HCL treatment | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cladribine s.c. injection, HCL treatment
- description
- Cladribine 0.14 mg/kg body weight for 5 consecutive days (d 1 - 5) as subcutaneous bolus injection for patients with hairy cell leukemia needing treatment
- interventionNames
- Drug: Cladribine s.c. injection, HCL treatment
Primary outcomes (1)
- measure
- Determination of the rate of complete remissions after one cycle with subcutaneous cladribine
- timeFrame
- 4 months after treatment
Secondary outcomes (1)
- measure
- Rate of complete remissions in patient who still have detectable residual disease
- timeFrame
- 4 months after treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.