E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with follicular Lymphoma grade I-IIIa and stage III-IV( as well as for selected patients with extended abdominal stageII). |
|
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 |
The primary end point of this prospective, nonrandomized phase II trial is the clinical and molecular remission rate in response to 90Y-ibritumomab tiutexan |
|
E.2.2 | Secondary objectives of the trial |
Senondary endpoints are: a) the time to progression following treatment with 90Y-ibritumomab tiutexan b) the ability of Rituximab consolidation therapy to induce a molecular remission in patients not achieving molecular remission 6 months after 90Y-ibritumomab tiutexan treatment and c) the safety and tolerability of 90Y-ibritumomab tiuxetan with particular respect to successive therapy strategies in patients relapsing after 90Y-ibritumomab tiutexan treatment. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients > 18 years old -Follicular lymphoma grade I,II or IIIa according to REAL/WHO calssification - -Ann Arbor stage III or IV or II with disseminated abdominal disease requiring extensive abdominal irradiation - No prior chemotherapy, immunotherapy or irradiation -Lymphoma cells positive for CD20 - Measurable disease -WHO/ECOG performance status 0-2 -Written informed consent |
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E.4 | Principal exclusion criteria |
-Bone marrow involvement only -Bone marrow infiltration>25% -Leukocytopenia<2500/microlitre -Thrombocytopenia<100 000/microlitre -Bulk lesions>10 cm -CNS lymphoma manifestation -Circulating tumor cells>500/micrilitre -Extensive pleural effusion/ascites(>1000 ml as estimated by ultrasound /CT) Severe concomitant disease(e.g. congestive heartfailure, myocardial infarction within 6 months of studystart, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease,liver disease) -Abnormal liver function:transaminases or total bilirubin>2 x upper limit of normal(unless caused by the lymphoma) -Abnormal renal function:serum creatinine >2 x upper limit of normal (unless caused by the lymphoma) -Previous malignanacy other than non melanoma skin cancer -Pregnant or breastfeeding (negative pregnancy test required for women of fertile age), no effective contraception -HIV positivity -Known hypersensitivity to foreign proteins, murine antibodies, presence of human anti-murine antibodies reactivity -Severe psychiatric illness |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this prospective, non randomized phase II trial is the clinical and molecular remission rate in response to 90Y-ibritumomab tiutexan. |
|
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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
|
The trial is closed when 60 patients have been treated. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |