Clinical trial · Interventional
Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab
Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia
NCT02157181CI-TRIAL-00080066completedPhase 2ClinicalTrials.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 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
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 (HCL) | Hairy Cell Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 2CdA +/- Rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCL, 2CdA +/- Rituximab
- description
- Risk stratification 1. HCL variant will be treated with cladribine plus rituximab, independent of previous therapy 2. Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is \< 3 years. 3. All repeated relapses (\> 1st relapse) after previous therapies with purine analogues and/or interferon will be treated with cladribine plus rituximab. Cladribine (LITAK®) 0.14 mg/kg daily Days 8-12 subcutaneous bolus injection Rituximab (Mabthera®) 375 mg/m2 daily Days 1, 8, 15, 22 infusion 4. Relapses of HCL will be treated with cladribine monotherapy, if the duration of remission of the previous therapy is \> 3 years. Cladribine (LITAK®) 0.14 mg/kg daily Days 1-5 subcutaneous bolus injection
- interventionNames
- Drug: 2CdA +/- Rituximab
Primary outcomes (1)
- measure
- Rate of complete remissions (CR)
- timeFrame
- 4 months after treatment
- description
- Determination of the rate of complete remission and duration of remission after one cycle of subcutaneous cladribine (LITAK®) plus four administrations of rituximab * in patients with hairy cell leukaemia variant * in patients with relapsed hairy cell leukaemia
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 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
References
Publications (0)
Data not yet available
No reference posted for this study.