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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

Tracking Information
First Submitted Date November 13, 2018
First Posted Date November 15, 2018
Last Update Posted Date June 4, 2020
Actual Study Start Date February 4, 2019
Estimated Primary Completion Date April 17, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2018)
Adverse Events (AEs) [ Time Frame: Up to approximately 5 years ]
Number of participants with adverse event
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ISTODAX® for Intravenous Infusion Drug Use Results Survey- Relapsed or Refractory Peripheral T-Cell Lymphoma
Official Title ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Lymphoma, T-Cell, Peripheral
Intervention Drug: Istodax
Istodax
Study Groups/Cohorts 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
Intervention: Drug: Istodax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2018)
130
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 17, 2023
Estimated Primary Completion Date April 17, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

N/A

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03742921
Other Study ID Numbers ROMI-PTCL-001
U1111-1222-2854 ( Registry Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Jinshu Cho, MD Celgene
PRS Account Celgene
Verification Date June 2020