Phase II study of 90Y ibritumomab tiuxetan (Zevalin) in patients with untreated follicular non-Hodgkin's lymphoma. - ZEUS

Phase 1

• Conditions: MedDRA version: 6.1Level: PTClassification code 10061170; Patients with untreated follicular non-Hodgkin's lymphoma grade 1 or 2 according to REAL classification.

• Registration Number: EUCTR2006-006808-11-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA SAN MARTINO GENOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-15
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified