E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Lymphocytic Leukemia |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic Lymphocytic Leukemia |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Blood and lymphatic diseases [C15] |
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 |
Progression-free survival:Clinically PFS is defined as the period from randomization until disease progression or death due to the underlying disease |
|
E.2.2 | Secondary objectives of the trial |
MRD-progression free survival>conversion rate to MRD negative>median MRD levels>conversion rate to CR>effect of MRD levels on clinical PFS and OS>event free survival>time to next treatment>overall survival>safety>benefit according to cytogenetic risk groups> |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•B-CLL •Age ≥18 •Previous Rituximab containing induction treatment of the CLL in 1st or 2nd line •Patient must be in complete remission or partial remission after an induction treatment containing rituximab •ANC (absolute neutrophil count) ≥ 1.0 x 109/L •Patient using a reliable means of contraception for the duration of the treatment including 2 months thereafter |
|
E.4 | Principal exclusion criteria |
•Active uncontrolled bacterial, viral or fungal infection •Positivity for HIV, Hepatitis B or C •Significantly reduced organ functions and bone marrow dysfunction not due to CLL •creatinine clearance of below 30 ml/min •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 •Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL)) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
This randomized Phase III trial aims to investigate the impact of Rituximab maintenance therapy vs. observation on the progression free survival of patients with first line or relapsed CLL |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
every 3 months over 4 years assessments done according to protocol |
|
E.5.2 | Secondary end point(s) |
MRD-progression free survival conversion rate to MRD negative median MRD levels conversion rate to CR effect of MRD levels on clinical PFS and OS event free survival time to next treatment OS safety benefit according to cytogenetic risk groups |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
every 3 months over 4 years assessments done according to protocol |
|
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 | No |
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) | 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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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 | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |