Hairy Cell Leukemia (HCL)
Conditions
Keywords
HCL variant, HCL relapse, Risk stratified
Brief summary
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
The trial is a prospective, multi-centre, open Phase II study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.
Interventions
DRUG2CdA +/- Rituximab
Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion
Sponsors
Jurgen Barth
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete remissions (CR) | 4 months after treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall remission rate (ORR) | 4 months after treatment | The rate of CR + PR will be determined |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acute and late toxicity | From day 1 of treatment period up to 120 months | All kind of adverse events, laboratory abnormalities, infections, unplanned hospitalisations will be measured |
| Degree of induced immunodeficiency | From day 1 of treatment period up to 120 months | Degree of immunosupression with CD4/CD8 quotient as indicating biomarker will be measured. Duration of immunosupression as well as infectious and other complications which result from therapy will be reported |
| Frequency of secondary neoplasia during the life-long follow-up period | From day 1 of treatment period up to 120 months | Rate of secondary neoplasia as safety issue will be determined |
| Overall survival (OS) | From achieving a remission until death | Determination of the overall survival times of all patients |
Countries
Germany
Outcome results
None listed