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ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03742921
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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Brief Summary:

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.

  1. Planned registration period 3 years and 6 months
  2. Planned surveillance period 4 years and 6 months

Condition or disease Intervention/treatment
Lymphoma, T-Cell, Peripheral Drug: Istodax

Study Design
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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : April 17, 2023
Estimated Study Completion Date : April 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Romidepsin

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Drug: Istodax
Istodax


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
    Number of participants with adverse event


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

- Patients who have been diagnosed with relapsed or refractory PTCL who receive Istodax for the first time.

Exclusion Criteria:

N/A

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742921


Contacts
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Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
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Japan
Nihon Seimei Hospital Recruiting
Osaka, Japan, 550-0006
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Jinshu Cho, MD Celgene
More Information
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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03742921    
Other Study ID Numbers: ROMI-PTCL-001
U1111-1222-2854 ( Registry Identifier: WHO )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Celgene:
Istodax
Survey
Relapsed or refractory
Peripheral T-Cell Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Romidepsin
Antibiotics, Antineoplastic
Antineoplastic Agents