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Zevalin Post-marketing Surveillance in Japan (ZEVALIN-DUI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01448928
First received: August 17, 2011
Last updated: November 23, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention
Non-Hodgkin's Lymphoma (NHL)
Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Zevalin

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions in subjects who received Zevalin [ Time Frame: After In-111 Zevalin administration, up to 13 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response [ Time Frame: After In-111 Zevalin administration, up to 8 years ] [ Designated as safety issue: No ]
  • Change in hemoglobin from baseline [ Time Frame: After In-111 Zevalin administration, up to 13 weeks ] [ Designated as safety issue: Yes ]
  • Change in neutrophil from baseline [ Time Frame: After In-111 Zevalin administration, up to 13 weeks ] [ Designated as safety issue: Yes ]
  • Change in platelet from baseline [ Time Frame: After In-111 Zevalin administration, up to 13 weeks ] [ Designated as safety issue: Yes ]
  • Change in leukocyte from baseline [ Time Frame: After In-111 Zevalin administration, up to 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: September 2008
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)
Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01448928

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01448928     History of Changes
Other Study ID Numbers: 15042
Study First Received: August 17, 2011
Last Updated: November 23, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Zevalin
CD20+
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014