E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic lymphocytic leukemia (CLL) |
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MedDRA Classification |
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 |
The main objective of this study is to determine the clinical rate of complete remissions (CR) of the regimen [Induction treatment with 3 cycles of R-FC, then three cycles of R-F. Patients in CR or PRcontinue with R maintenance therapy (1 infusion every three months) for two years.]. The best response at any point of treatment/maintenance will be determined. |
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E.2.2 | Secondary objectives of the trial |
• CR, PRand nPR rate after 3 courses of induction; after 6 courses of induction; and during Rituximab maintenance • Time to next treatment • Molecular CR after 3 courses of induction; after 6 courses of induction; and during Rituximab maintenance • overall toxicity of the regimen (all grades • Cytogenetic risk profile and sensitivity to the regimen • Molecular risk profile as determined by microarray RNA analysis • mutational status of IgVH genes via ZAP-70 expression detection
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• B-CLL (as determined by CD23+, CD5+, CD19+, CD20+) • Treatment indication as defined by the NCI Workshop criteria (see append 5 and Ref 10) • Age ≥18 • ECOG performance status 0-2 • No previous treatment of the CLL by chemotherapy, radiotherapy or immunotherapy • Life expectancy > 6 months • Patient's written informed consent • Patient using a reliable means of contraception (e.g. physical barrier, contraceptive pill or patch, spermicide and barrier, or IUD) for the duration of the treatment including 2 months thereafter
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E.4 | Principal exclusion criteria |
• Active bacterial, viral or fungal infection • Positivity for HIV, Hepatitis B or C • positive Coombs Test and/or autoimmune hemolytic anemia • reduced organ functions and bone marrow dysfunction not due to CLL • creatinine clearance of below 30 ml/min (calculation of crea. clearance: appendix 6) • Patients with a history of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent. • Patients with medical co-morbid conditions that would require long term
use (> 1 month) of systemic corticosteroids during study treatment • Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring ongoing treatment, or unstable angina • Other known co-morbidity with the potential to dominate survival • Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL) • Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any of the applied drugs • Pregnant or breast feeding women • Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is to determine the clinical rate of complete remissions (CR) of the regimen. The best response at any point of treatment/maintenance will be determined. |
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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 | No |
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 | No |
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 | No |
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 | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |