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

Completed

• Conditions: Lymphoma, T-Cell, Peripheral
• Interventions: Drug: Istodax

• Registration Number: NCT03742921
• Lead Sponsor: Celgene

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 4 years

2. Planned surveillance period 5 years and 6 months

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-13
• Study First Posted: 2018-11-15
• Study Start: 2019-02-04
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsed or Refractory T-Cell Lymphoma patients with Istodax	Istodax	Among patients with relapsed or refractory peripheral T-Cell lymphoma, patients who received Istodax will be targeted in this surveillance

Primary Outcome Measures

Name	Time	Method
Adverse Events (AEs)	Up to approximately 5 years	Number of participants with adverse event

Trial Locations

Locations (1)

Nihon Seimei Hospital; 🇯🇵 Osaka, Japan