Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia With Cladribine Plus Rituximab

Study Overview
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Brief Summary
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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

Detailed Description
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The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Official Title
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Study on the Treatment of Hairy Cell Leukaemia Variant and Relapsing Hairy Cell Leukaemia

Conditions
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Hairy Cell Leukemia (HCL)

Intervention / Treatment
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* Drug: 2CdA +/- Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HCL, 2CdA +/- Rituximab<br>Risk stratification HCL variant will be treated with cladribine plus rituximab, independent of previous therapy Relapses of HCL will be treated with cladribine plus rituximab, duration of remission of the previous therapy is < 3 years. 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 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 | Drug: 2CdA +/- Rituximab<br>* Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion<br>* Other names: Rituximab (Mabthera®; Rituxan®) 375 mg/m²;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complete remissions (CR) | 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 | 4 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall remission rate (ORR) | The rate of CR + PR will be determined | 4 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCL variant, HCL relapse, Risk stratified