Patients with untreated follicular non-Hodgkin's lymphoma grade 1 or 2 according to REAL classification. MedDRA version: 6.1 Level: PT Classification code 10061170
Conditions
Interventions
Trade Name: ZEVALIN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Monoclonal antibodies
Other descriptive name: IBRITUMOMAB TIUXETANO
Concentration unit: mg milligram(s)
Concentrat
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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. | — |
Countries
Italy
Outcome results
None listed