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 stage II). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052314 |
E.1.2 | Term | Lymphatic disorder |
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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 tiuxetan. |
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E.2.2 | Secondary objectives of the trial |
The secondary end points are: a) the time to progression following treatment with 90Y-ibritumomab tiuxetan, b) the ability of Rituximab consolidation therapy to induce a molecular remission in patients not achieving molecular remission 6 months after 90Y-ibritumomab tiuxetan treatment, and c) the safety and tolerability of 90Y-ibritumomab tiuxetan with particular respect to successive therapy strategies in patients relapsing after 90Y-ibritumomab tiuxetan treatment. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patient > 50 years old •Follicular lymphoma grade I, II, or IIIa according to REAL/WHO classification •Ann Arbor stage III, or IV, or stage II with disseminated abdominal disease requiring extensive abdominal irradiation •No prior chemotherapy, immunotherapy, or irradiation •Lymphoma cells positive for CD20 •Measurable disease (two perpendicular diameters by either physical or radiological examination) •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 < 2.500 /µl •Thrombocytopenia < 100.000 /µl •Bulk lesions > 10 cm •CNS lymphoma manifestation •Circulating tumor cells > 500 /µl •Extensive pleural effusion/ascites (> 1000 ml as estimated by ultrasound/CT) •Severe concomitant diseases (e.g. congestive heart failure, myocardial infarction within 6 months of study, severe uncontrolled hypertension, renal insufficiency requiring hemodialysis, pulmonary disease, liver disease) •Abnormal liver function: transaminases or total bilirubin > 2 x upper limit of normal (ULN) (unless caused by the lymphoma) •Abnormal renal function: serum creatinine > 2 x upper limit of normal (unless caused by the lymphoma) •Previous malignancy other than non-melanoma skin cancer •Pregnant or breast feeding female patients (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 (HAMA) reactivity •Severe psychiatric illness
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary end point of this prospective, nonrandomized phase II trial is the clinical and molecular remission rate in response to 90Y-ibritumomab tiuxetan. |
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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) | 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 | 5 |
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
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The trial is closed if 60 patients have been treated. |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |