Clinical trial · Interventional
Zevalin® First Line in Follicular Lymphoma
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
NCT00772655CI-TRIAL-00007712unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a European multicenter study of 90Yttrium-Ibritumomab Tiuxetan (90Y-Ibritumomab Tiuxetan) (Zevalin®) as a front line therapy for patients with follicular lymphoma grade I-IIIa and stage III-IV (as well as for selected patients with extended abdominal stage II). For patients with complete clinical remission but persistent molecular disease subsequent to 90Y-Ibritumomab Tiuxetan treatment a consolidation immunotherapy with Rituximab is added, to eradicate minimal residual disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Study Therapy
- description
- 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.
- interventionNames
- Drug: 90Yttrium-Ibritumomab Tiuxetan (Zevalin®)+Rituximab
- Drug: Rituximab
Primary outcomes (1)
- measure
- Clinical and molecular remission rate after primary therapy with 90Y-Ibritumomab Tiuxetan
- timeFrame
- 6 months from entry onto trial
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDRieger K, De Filippi R, Linden O, Viardot A, Hess G, Lerch K, Neumeister P, Stroux A, Peuker CA, Pezzutto A, Pinto A, Keller U, Scholz CW. 90-yttrium-ibritumomab tiuxetan as first-line treatment for follicular lymphoma: updated efficacy and safety results at an extended median follow-up of 9.6 years. Ann Hematol. 2022 Apr;101(4):781-788. doi: 10.1007/s00277-022-04781-3. Epub 2022 Feb 12. PMID 35150296
- DERIVEDScholz CW, Pinto A, Linkesch W, Linden O, Viardot A, Keller U, Hess G, Lastoria S, Lerch K, Frigeri F, Arcamone M, Stroux A, Frericks B, Pott C, Pezzutto A. (90)Yttrium-ibritumomab-tiuxetan as first-line treatment for follicular lymphoma: 30 months of follow-up data from an international multicenter phase II clinical trial. J Clin Oncol. 2013 Jan 20;31(3):308-13. doi: 10.1200/JCO.2011.41.1553. Epub 2012 Dec 10. PMID 23233718