Trial Condition(s):
Non-Hodgkin''s Lymphoma (NHL)
STUDY SPONSORSHIP TRANSFERRED - Zevalin post-marketing surveillance in Japan (ZEVALIN-DUI)
Bayer Identifier:
15042
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
DISCLAIMER: This study was originally conducted and disclosed under Bayer sponsorship; sponsorship was however transferred to a new sponsor while the study was still ongoing. Therefore, this disclosure overview only reflects the study status at the last time that Bayer was responsible for the study – for the latest correct status and details of the study, please refer to the disclosure by the new sponsor under the study’s NCT number on www.ClinicalTrials.gov.
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Drug use investigation of Zevalin
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions in subjects who received ZevalinTimeframe: After In-111 Zevalin administration, up to 13 weeks
- Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received ZevalinTimeframe: After In-111 Zevalin administration, up to 8 years
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]Timeframe: After In-111 Zevalin administration, up to 13 weeks
- Effectiveness evaluation assessment [complete remission rate, complete remission uncertain rate, partial remission rate, stable disease rate, progression disease rate] by investigator-determined overall best responseTimeframe: After In-111 Zevalin administration, up to 13 weeks
- Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best responseTimeframe: After In-111 Zevalin administration, up to 8 years
- Change in hemoglobin from baselineTimeframe: After In-111 Zevalin administration, up to 13 weeks
- Change in neutrophil from baselineTimeframe: After In-111 Zevalin administration, up to 13 weeks
- Change in platelet from baselineTimeframe: After In-111 Zevalin administration, up to 13 weeks
- Change in leukocyte from baselineTimeframe: After In-111 Zevalin administration, up to 13 weeks
Additional Information
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