ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
To ascertain the safety and efficacy of Istodax® in actual clinical settings in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) who receive Istodax.
- Planned registration period 4 years
- Planned surveillance period 5 years and 6 months
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Osaka, Japan, 550-0006
- Nihon Seimei Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Since the number of patients with PTCL was 48 and 131 in the Japanese and overseas clinical studies, respectively, the number of subjects to be surveyed was established at 130 to allow comparison of results between this survey and Japanese clinical study, or between this survey and overseas clinical study.
Among events that were established as the key survey items of this survey, QT interval prolonged had the lowest incidence (3.8%) in the overseas/Japanese clinical studies of Istodax in patients with PTCL. When 130 subjects are collected, it would be possible to collect at least 1 case of an event that occurs at the frequency of 2.3% with a reliability of 95%. Thus, assuming that adverse events occur under the actual use conditions at similar frequencies as in clinical studies, it would be possible to obtain at least 1 case of all events that have been established as the key survey items.
Description
Inclusion Criteria:
- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.
Exclusion Criteria:
N/A
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Relapsed or Refractory T-Cell Lymphoma patients with Istodax
Among patients with relapsed or refractory peripheral T-Cell lymphoma, patients who received Istodax will be targeted in this surveillance
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Istodax
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events (AEs)
Time Frame: Up to approximately 5 years
|
Number of participants with adverse event
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Up to approximately 5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jinshu Cho, MD, Celgene
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antibiotics, Antineoplastic
- Histone Deacetylase Inhibitors
- Romidepsin
Other Study ID Numbers
- ROMI-PTCL-001
- U1111-1222-2854 (Registry Identifier: WHO)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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