E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
MALT lymphoma of the ocular adnexae |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061850 |
|
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 |
1. To explore the role of antibiotic therapy in the treatment of MLOA and correlate the treatment response to molecular genetic findings.
2. To comprehensively screen infectious agents associated with chronic eye infection including Chlamydia, herpes simplex virus and adenovirus in MLOA and various controls (other types of ocular adnexal lymphomas, inflammatory conditions) using molecular, immunohistological and serological tests with a view to identifying the agents associated with these lymphomas. |
|
E.2.2 | Secondary objectives of the trial |
1. Identification of the infectious agents associated with MLOA
2. Geographical variation in distribution of potential infective agents associated with MLOA in particular Chlamydia species
3. Molecular factors associated with response/non-response to tetracycline in MLOA |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Age 16 years or over
2. Histologically confirmed marginal zone B-cell lymphoma of MALT-type
3. Lymphoma localised to the ocular adnexae (conjunctiva, lacrymal gland, orbit soft tissue, clinical stage IEA) 4. No previous treatment, excepting RT for localised lymphoma of the contralateral eye
5. At least one measurable lesion
6. No systemic antibiotic therapy in the last three months
7. No other malignancy in the previous 5 years apart from appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
8. In women with reproductive potential a willingness to use contraception from entry
into the study for a period of 3 months
9. Written informed consent |
|
E.4 | Principal exclusion criteria |
1. Pregnant or lactating women
2. Known allergy to tetracycline
3. Patients unwilling to comply with the requirements of follow-up as defined by this protocol
4. Myasthenia gravis (tetracycline can exacerbate muscle weakness)
5. Systemic lupus erythematous (tetracycline can exacerbate the condition)
6. Patients with large or rapidly enlarging tumours requiring immediate radiotherapy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Response rates and duration of response to tetracycline in patients with MALT lymphoma of the ocular adnexae (MLOA) |
|
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 | 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) | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |