Patients with follicular lymphoma grade I-IIIa and stage III–IV (as well as for selected patients with extended abdominal stage II). MedDRA version: 8.1 Level: LLT Classification code 10052314 Term: Lymphatic disorder
Conditions
Interventions
Trade Name: Zevalin
Product Name: 90Yttrium-Ibritumomab tiuxetan
Product Code: Therapeutic Radiopharmaceutical
Pharmaceutical Form: Injection*
Trade Name: MabThera
Product Name: Rituximab
Product Co
Sponsors
Charité-Universitätsmedizin Berlin, Germany
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •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
Exclusion criteria
Exclusion criteria: •Bone marrow involvement only •Bone marrow infiltration > 25% •Leukocytopenia 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Austria, Germany, Sweden
Outcome results
None listed