E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients diagnosed with chronic lymphocytic leukemia (CLL) according to the WHO guidelines, within 18 and 71 years and not previously treated |
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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 |
To asess feasibility and toxicity of the quemotherapeutic regimen rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) plus maintenance treatment with rituximab. |
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E.2.2 | Secondary objectives of the trial |
1. Response rate of the R-FCM 2. Relationship between biological markers and response 3. Response duration and progression free survival 4. Pharmacokynetic parameters |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Age > 17 and < 71 years 2. ECOG ≤ 3 3. Patients diagnosed with CLL according to the standard criteria 4. Active disease defined with the presence of one of the following: - weight loss > 10% within the previous 6 months - Extreme fatigue - Fever > 38oC for > 2 weeks without evidence of infection - Night sweets without evidence of infection - Progressive bone marrow failure as manifested by the development of anemia and/or thrombocytopenia - massive or progressive splenomegaly - massive or progressive lymphadenopathy - progressive lymphocytosis with an increase of > 50% over a 2-month period, or anticipated doubling time of less than 6 months - Patients not previously treated - Informed consent signed |
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E.4 | Principal exclusion criteria |
- Age < 18 and > 70 years - previously treated patients - Transformed CLL to a more hystological agressive forms - patients with severe cardiac, pulmonar, neurological, psychiatric or metabolical conditions. - patients receiving high dose of corticosteroid therapies - abnormal hepatic (bilirrubin, ASAT, ALAT, GGT > 2 times the normal values) not related to the CLL - abnormal renal function (creatinin > 1.5 times the normal value or clearance of creatinine < 50 mL/min - Patients diagnosed with other neoplastic conditions (except for localized cutaneous carcinoma) - autoimmune anemia or thrombocytopenia or positive Coombs's test - severe and active infection - pregnancy or breast feeding period - HIV positivity or other sever immunosupressive diseases - Positive HBsAg, HBcAb, or CHV - Participation in another clinical trial
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E.5 End points |
E.5.1 | Primary end point(s) |
1. To asess feasibility and toxicity of the quemotherapeutic regimen rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) plus treatment maintenance with rituximab. 2. Response rate of the R-FCM 3. Relationship between biological markers and response 4. Response duration and progression free survival 5. Pharmacokynetic parameters |
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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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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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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 | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |