E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
previously untreated Binet stage A CLL patients at high risk of disease progression |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008943 |
E.1.2 | Term | Chronic leukaemia |
|
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 |
A comparison of the effect of immediate treatment with CAM versus deferred treatment in clinical Binet stage A patients at high risk for disease progression, in terms of Progression Free Survival PFS . |
|
E.2.2 | Secondary objectives of the trial |
For all patients 1. Quality of Life QoL 2. Event Free Survival EFS /Time to Treatment Failure TTF 3. Time to next treatment 4. Time to second treatment 5. Overall survival OS For patients included in the early treatment arm 1.Complete Response CR , Partial Response PR and Overall Response Rate ORR . 2. Safety profile of early treatment with CAM For patient in the early treatment arm achieving CR 1. Minimal Residual Disease MDR detected by flow-cytometry 2. Disease free survival DFS , calculated from the date of the response achievement to the date of relapse |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Previously untreated male and female patients with Binet stage A CLL who do not necessitate therapy, according to NCI criteria and newly diagnosed not more than 12 months before registration . 7.1 Inclusion Criteria 1 Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis CD5 /CD19 /CD23 . 2 Age 18 years and 70 years 3 Binet stage A Appendix B 4 Diagnosis performed within 12 months before inclusion in the study 5 All patients with Binet stage A disease who do not necessitate therapy by NCI criteria guidelines should be included 6 Patients at high risk of disease progression for the presence of 2 or more of the following risk factors a CD38 30 b Zap-70 strong at Western Blot analysis c IgVH status unmutated degree of homology 2 7 ECOG performance status 0 2 Appendix C 8 ................... |
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E.4 | Principal exclusion criteria |
1 Patients with CLL whose diagnosis exceed 12 months before inclusion in the study 2 Age 70 and 18 years 3 ECOG performance status 2 4 Patients with leukemic phase of lymphoproliferative disorders of B-cell origin CD5- and/or CD23- according to flow cytometry analysis 5 Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease 6 Medical condition requiring the prolonged estimated to be more than one month use of oral corticosteroids 7 History of anaphylactic reaction following exposure to humanized monoclonal antibodies 8 Patients with active bacterial, viral or fungal infection 9 HIV positivity, HBV and HBC positivity assessed by DNA copies 10 CMV status as evaluated by pathological values detected by CMV specific quantitative 11 ............ |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Progression Free survival PFS |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 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 | Yes |
E.8.2.3.1 | Comparator description |
|
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
| |
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 | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |