E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019053 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 0 |