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Currently, you can access the following clinical trials being conducted worldwide:

342,868 studies
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

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

Clinicaltrials.gov identifier NCT03742921

Recruitment Status Recruiting

First Posted November 15, 2018

Last update posted June 4, 2020

Study Description

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:Lymphoma, T-Cell, Peripheral
  • Intervention/Treatment: Drug: Istodax
  • Phase: N/A
Detailed Description

N/A

Study Design
  • 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 2019
  • Estimated Primary Completion Date: April 2023
  • Estimated Study Completion Date: April 2023
Groups and Cohorts
Groups/Cohorts 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
  • Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
    Number of participants with adverse event
Eligibility Criteria
  • 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
Contacts

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

Locations

Japan
Nihon Seimei Hospital
Osaka

Sponsors and Collaborators

Celgene

Investigators

Study Director: Jinshu Cho, MD Celgene

More Information
  • Responsible Party: Celgene
  • ClinicalTrials.gov Identifier: NCT03742921 History of Changes
  • Other Study ID Numbers: ROMI-PTCL-001, U1111-1222-2854
  • First Posted: November 15, 2018 Key Record Dates
  • Last Update Posted: June 4, 2020
  • Last Verified: June 2020
  • 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.: Yes
  • Keywords provided by Celgene: Istodax
    Survey
    Relapsed or refractory
    Peripheral T-Cell Lymphoma
  • Additional relevant MeSH terms: Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral