Clinical trial · Observational
Zevalin Post-marketing Surveillance in Japan
Drug Use Investigation of Zevalin
- 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 study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.
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 |
|---|---|---|---|
| Non-Hodgkin's Lymphoma (NHL) | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- interventionNames
- Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Primary outcomes (2)
- measure
- Incidence of adverse drug reactions in subjects who received Zevalin
- timeFrame
- After In-111 Zevalin administration, up to 13 weeks
- measure
- Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
- timeFrame
- After In-111 Zevalin administration, up to 8 years
Secondary outcomes (7)
- measure
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: Patients who received Zevalin for relapsed or refractory: * CD20+ * low grade B-cell non-Hodgkin's lymphoma * Mantle cell lymphoma Exclusion Criteria: * Patients who are contraindicated based on the product label
References
Publications (0)
Data not yet available