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

NCT ID: NCT03742921

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-04

Study Completion Date

2023-10-31

Brief Summary

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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

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Conditions

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Lymphoma, T-Cell, Peripheral

Keywords

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Istodax Survey Relapsed or refractory Peripheral T-Cell Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Istodax

Intervention Type DRUG

Istodax

Interventions

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Istodax

Istodax

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jinshu Cho, MD

Role: STUDY_DIRECTOR

Celgene

Locations

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Nihon Seimei Hospital

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1222-2854

Identifier Type: REGISTRY

Identifier Source: secondary_id

ROMI-PTCL-001

Identifier Type: -

Identifier Source: org_study_id