E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis of CNS relapse in adult patients with aggressive Non-Hodgkin-Lymphomas at risk for CNS metastasis |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029547 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Incidence of confirmed leptomeningeal metastasis (CNS relapse) during the post treatment observation period of one year verified by CNS cytology
|
|
E.2.2 | Secondary objectives of the trial |
- Overall safety profile (adverse events, laboratory, vital signs) - Survival (all cause) - Time to confirmed CNS relapse |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Informed consent - Male and female, age ≥ 18 years - Histological proven aggressive Non-Hodgkin-Lymphoma at risk and eligible for R-CHOP therapy (newly diagnosed patients) respectively R-ICE therapy (systemically relapsed patients) and
A. ONE of the following extranodal sites: * Testis involvement * High cervical involvement (nasal/paranasal sinuses, orbita, epidural space, parotid and submandibular glands, ear, throat region) * Bone marrow involvement
AND ONE of the following risk factors: * Extranodal sites > 1 * LDH > 450 U/l
OR
B. Both of the following risk factors: * Extranodal sites > 1 * LDH > 450 U/l
- Negative CSF-cytology - Karnofsky ≥ 60% - Females of child-bearing potential must have a negative (urine or serum) pregnancy test and effective methods to prevent pregnancy. |
|
E.4 | Principal exclusion criteria |
- Histology of lymphoma not eligible for R-CHOP or R-ICE treatment - Uncontrolled infection including HIV infection - Any previous CNS tumor therapy - Known or suspected CNS metastasis - Previous history of any CNS disease or present condition which is regarded as contraindication for intrathecal chemotherapy - Patients unable to comply with trial procedures - Pregnancy and lactation - Any other investigational drug within 21 days prior to trial entry |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of confirmed leptomeningeal metastasis (CNS relapse) during the post treatment observation period of one year verified by CNS cytology |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
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 | 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) | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 | No |
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
|
end of the trial corresponds to last visit of last subject |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |