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 stage II).MedDRA version: 8.1Level: LLTClassification code 10052314Term: Lymphatic disorder
- Registration Number
- EUCTR2006-005778-34-DE
- Lead Sponsor
- Charité-Universitätsmedizin Berlin, Germany
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
•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
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
•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
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 tiuxetan. ;Secondary Objective: 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. ;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.
- Secondary Outcome Measures
Name Time Method