Zevalin® First Line in Follicular Lymphoma
Follicular Lymphoma
About this trial
This is an interventional treatment trial for Follicular Lymphoma focused on measuring Follicular Lymphoma, First line therapy, Zevalin, 90Yttrium-Ibritumomab Tiuxetan, Yttrium, Rituximab, Radio-immuno therapy
Eligibility 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. Furthermore, when receiving therapy as part of this "Zevalin® first line in follicular lymphoma" trial and up to six months after therapy has ended, patients may not participate in another clinical trial. If patients receive consolidation therapy with Rituximab, the six months period is counted from the end of the consolidation therapy.
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Experimental
Study Therapy
Induction therapy with a single course of 90Yttrium-Ibritumomab Tiuxetan (according to the standard procedure that includes Rituximab 250 mg/m2 plus 111Indium-Ibritumomab Tiuxetan for dosimetry on day one followed by Rituximab 250 mg/m2 and 90Y-Ibritumomab Tiuxetan 15 MBq/kg on day 8 or 9 up to a maximal dose of 12.000 MBq [if platelets are below 150000/µl only 11 MBq/kg are administered). Observation for patients achieving complete clinical and molecular response or partial clinical response. Consolidation/maintenance therapy with 4 weekly courses of Rituximab 375 mg/m2 followed by 4 bimonthly courses of Rituximab 375 mg/m2 for patients in clinical CR but with persistent Bcl-2 (t14;18)-positivity 6 months after 90Y-Ibritumomab Tiuxetan.