Zevalin Post-marketing Surveillance in Japan

NCT01448928 | Completed

• 1 other identifier: 15042
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non-Hodgkin's Lymphoma (NHL)

Keywords

Zevalin; CD20+; Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse drug reactions in subjects who received Zevalin

  After In-111 Zevalin administration, up to 13 weeks

• Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin

  After In-111 Zevalin administration, up to 8 years

Secondary Outcomes (7)

• Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]

  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 response

  After In-111 Zevalin administration, up to 13 weeks

• Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response

  After In-111 Zevalin administration, up to 8 years

• Change in hemoglobin from baseline

  After In-111 Zevalin administration, up to 13 weeks

• Change in neutrophil from baseline

  After In-111 Zevalin administration, up to 13 weeks

Study Arms (1)

Group 1

Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Interventions

[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128) DRUG

Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.

Group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400cases: This study is all case investigation of which the enrollment period is five years, and all patients who received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma will be recruited.

You may qualify if:

• Patients who received Zevalin for relapsed or refractory:
• CD20+
• low grade B-cell non-Hodgkin's lymphoma
• Mantle cell lymphoma

You may not qualify if:

• Patients who are contraindicated based on the product label

Sponsors & Collaborators

• Spectrum Pharmaceuticals, Inc: lead
• Bayer: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell

Interventions

ibritumomab tiuxetan

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: October 7, 2011
• Study Start: September 1, 2008
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

JP (1)