Multicenter European pilot study of 90Yttrium-ibritumomab tiuxetan as first line therapy for stage III-IV follicular lymphoma (and selected patients with extended stage II) followed by consolidation Rituximab for patients in complete remission but with persistent molecular disease. - Zevalin first line in Follicular lymphoma

• Conditions: Patients with follicular Lymphoma grade I-IIIa and stage III-IV( as well as for selected patients with extended abdominal stageII).

• Registration Number: EUCTR2006-005778-34-SE
• Lead Sponsor: Charite-Universitätsmedizin Berlin Germany

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

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
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

-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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary end point of this prospective, nonrandomized phase II trial is the clinical and molecular remission rate in response to 90Y-ibritumomab tiutexan ;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.;Secondary Objective: 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.