Patients with histologically verified HCL classical HCL presence of HCs in the bone marrow and in the peripheral blood detected by positive TRAP staining and positive DBA44 and/or co-expression of the cell surface-antigens CD19/CD25 or CD19/CD 103. No previous cytostatic treatment with ECOG status 0-2. Current histology, which should not be older than 6 months Level: PT Classification code 10019053
Conditions
Interventions
Trade Name: Litak
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Cladribine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product Name: Lit
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically verified HCL classical HCL presence of HCs in the bone marrow and in the peripheral blood detected by positive TRAP staining and positive DBA44 and/or co-expression of the cell surface-antigens CD19/CD25 or CD19/CD 103 No previous cytostatic treatment Need for treatment is indicated see 5.3 Age at least 18 years ECOG status 0-2 Current histology, which should not be older than 6 months Written consent by the patient Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients not fulfilling the above-mentioned inclusion criteria Pre-treatment with purine analogs or other chemotherapeutics Concomitant corticosteroid therapy Patients with severe dysfunction of the heart according to NYHA III/IV, of the lung according to WHO grade 3/4, of the liver except when due to lymphoma bilirubin 2 mg/dl; alkaline phosphatase, GOT and GPT increased more than twice the normal value , the kidneys creatinine 2 mg/dl, or creatinine clearance 50 mg/min , as well as patients with diseases of the central nervous system, including psychoses ECOG status 2 Patients with proven HIV infection Patients with active hepatitis Patients with other florid infections Patients with anamnesis / diagnosis of another malignant disease other than non-melanoma associated skin tumors or stage 0 in situ carcinoma of the cervix Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1 to evaluate response rates complete remission and partial remission rates of cladribine in the two groups of patients randomised to receive subcutaneous bolus injection of cladribine LITAK either for 5 arm A or for 7 arm B consecutive days. 2 to determine acute and late toxicity in the two arms of treatment with particular evaluation of hematological toxicity and incidence of infectious complications.;Secondary Objective: to determine the duration of responses in the two arms of treatment the time elapsed from the end of treatment up to progression or recurrence of disease in patients who have responded to treatment . to determine the frequency of secondary neoplasia during the life-long follow-up period. to identify biological or molecular parameters able to predict responses to treatment.;Primary end point(s): to evaluate response rates complete remission and partial remission rates of cladribine in the two groups of patients randomised to receive subcutaneous bolus injection of cladribine LITAK either for 5 arm A or for 7 arm B consecutive days. to determine acute and late toxicity in the two arms of treatment with particular evaluation of hematological toxicity and incidence of infectious complications. | — |
Countries
Italy
Outcome results
None listed