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Completed

NCT Number: NCT01448928

Zevalin Post-marketing Surveillance in Japan

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.

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Key information

Conditions

Non-Hodgkin's Lymphoma (NHL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[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.

Primary outcomes

  1. Incidence of adverse drug reactions in subjects who received Zevalin

    Time frame: After In-111 Zevalin administration, up to 13 weeks

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

    Time frame: After In-111 Zevalin administration, up to 8 years

Secondary outcomes

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

    Time frame: After In-111 Zevalin administration, up to 13 weeks

  2. 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

    Time frame: After In-111 Zevalin administration, up to 13 weeks

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

    Time frame: After In-111 Zevalin administration, up to 8 years

  4. Change in hemoglobin from baseline

    Time frame: After In-111 Zevalin administration, up to 13 weeks

  5. Change in neutrophil from baseline

    Time frame: After In-111 Zevalin administration, up to 13 weeks

  6. Change in platelet from baseline

    Time frame: After In-111 Zevalin administration, up to 13 weeks

  7. Change in leukocyte from baseline

    Time frame: After In-111 Zevalin administration, up to 13 weeks

Sponsors and collaborators

Lead sponsor

Spectrum Pharmaceuticals, Inc

Industry

Collaborators

  • Bayer

Registry information

Official study title

Drug Use Investigation of Zevalin

Acronym: ZEVALIN-DUI

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Oct 7, 2011
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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