stop_circleTerminated/Withdrawn

Non-Hodgkin''s Lymphoma (NHL)

Bayer Identifier:

15042

ClinicalTrials.gov Identifier:

NCT01448928

EudraCT Number:

Not Available

EU CT Number:

Not Available
STUDY SPONSORSHIP TRANSFERRED - Zevalin post-marketing surveillance in Japan

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • Patients who received Zevalin for relapsed or refractory:
    - CD20+
    - low grade B-cell non-Hodgkin’s lymphoma
    - Mantle cell lymphoma
  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
413
Trial Dates
September 2008 - February 2014
Phase
Phase 4
Could I Receive a placebo
No
Products
Zevalin (Ibritumomab tiuxetan, BAY86-5128)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions in subjects who received Zevalin
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of serious adverse events, especially secondary malignant tumors, in subjects who received Zevalin
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, medical history data, clinical staging]
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    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
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Effectiveness evaluation assessment [progression free survival] by investigator-determined overall best response
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 8 years
    enhanced_encryption
    Safety Issue:
    No
  • Change in hemoglobin from baseline
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in neutrophil from baseline
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in platelet from baseline
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Change in leukocyte from baseline
    date_rangeTime Frame:
    After In-111 Zevalin administration, up to 13 weeks
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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