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
• Sponsor: Celgene
• 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
• 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

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

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