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

NCT03742921 | Completed FDA Drug

• 2 other identifiers: ROMI-PTCL-001U1111-1222-2854
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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. 1.Planned registration period 4 years
2. 2.Planned surveillance period 5 years and 6 months

Conditions

Lymphoma, T-Cell, Peripheral

Keywords

Istodax; Survey; Relapsed or refractory; Peripheral T-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Adverse Events (AEs)

  Number of participants with adverse event

  Up to approximately 5 years

Study Arms (1)

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

Interventions

Istodax DRUG

Istodax

Relapsed or Refractory T-Cell Lymphoma patients with Istodax

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Nihon Seimei Hospital

Osaka, 550-0006, Japan

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Recurrence

Interventions

romidepsin

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jinshu Cho, MD

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 15, 2018
• Study Start: February 4, 2019
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-12

Locations

JP (1)