E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with untreated follicular non-Hodgkin's lymphoma grade 1 or 2 according to REAL classification. |
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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 | 10061170 |
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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 objective of the study is to verify the effectiveness and the safety of the use of one single dose of 90Y ibritumomab tiuxetan like front line of treatment in patients with follicular lymphoma non-Hodgkin, verifying the incidence of complete and partial answers. The answers will be estimated are from the clinical point of view that radiological and molecular through test PCR in order to verify translocation t (14; 18) and the IgH rearrangement. |
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E.2.2 | Secondary objectives of the trial |
Objectives secondary are: the survival lacking in disease; the safety of the single dose of 90Y ibritumomab tiuxetan in terms of haematological and ematochimica toxicity; the duration of the answer; the quality of the life; the surveillance about the appearance of acute leukaemia. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Confirmed histological (according to the REAL/WHO classification) CD20 positive follicular, grade 1 or 2, non-Hodgkin's lymphoma, stage II bulky (node > 5 cm), III or IV at diagnosis time point; - Age > 18 years; - World Health Organization (WHO) performance status of 0 to 2; - Bone marrow involvement of disease 25% (measurement of bone marrow biopsy); - Platelet count of 150,000 x 103/ml or higher; - Haemoglobin (Hb) of 9 g/dl (90 g/l) or higher; - At least one bidimensionally measurable lesion (according to CT-scan); - Life expectancy of at least 3 months; - Written informed consent. |
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E.4 | Principal exclusion criteria |
Any prior anticancer treatment for NHL; - Prior radiation therapy; - Prior myeloabletive therapy; - Any other malignancy or history of prior malignancy except non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma within the past ten years; - Presence of syntomatic CNS lynphoma; - Patients with known HIV positivity; - Patients with known active infection uncontrolled by treatment; - Patients with pleural effusion or ascites; - Patients with abnormal liver function: total bilirubin > 1.5 x upper limits of normal (ULN) or ALAT >2.5 x ULN; - Patients with abnormal renal function: serum creatinine > 2.5 x ULN; - IgG < 3 g/l; - Known hypersensitivity to murine antibodies or proteins; - Pregnant or breast feeding female patients, or adult reproductive potential not employing an effective method of birth control during study treatment and for at least 12 months thereafter; - Ongoing severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, severe uncontrolled hypertension, chronic renal disease, or active uncontrolled infection) which could compromise participation in the study; - Patients who received any investigational drugs less than 4 weeks before entry in this study; - Patients who underwent surgery within 4 weeks of entering the study or patients who have not as yet recovered from the side-effects of such treatment; - Patients with a history of psychiatric illness or condition which could interfere with their ability to understand the requirements of the study; - Patients unwilling or unable to comply with the protocol. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The aim of this study is to evaluate the efficacy and safety of a single dose of 90Y ibritumomab tiuxetan as first line treatment in follicular non-Hodgkin lymphoma. |
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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 | 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 | Yes |
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 | No |
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 | 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
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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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |