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NCT03742921 Clinical Trial

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

Lymphoma, T-Cell, Peripheral Clinical Trial

Official title:
ISTODAX® for Intravenous Infusion 10mg Drug Use Results Survey - Relapsed or Refractory Peripheral T-Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03742921
Other study ID # ROMI-PTCL-001
Secondary ID U1111-1222-2854
Status Completed
Phase
First received
Last updated
Start date February 4, 2019
Est. completion date October 31, 2023

Study information
Verified date December 2023
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Istodax
Istodax

Locations
Country Name City State
Japan Nihon Seimei Hospital Osaka

Sponsors (1)
Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events (AEs) Number of participants with adverse event Up to approximately 5 years
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