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A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)

NCT ID: NCT05137847

Last Updated: 2023-12-12

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

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-24

Study Completion Date

2023-03-17

Brief Summary

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The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).

Detailed Description

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Conditions

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Lymphoma, T-cell, Peripheral Lymphoma, T-cell, Cutaneous

Keywords

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Peripheral T cell lymphoma Cutaneous T cell lymphoma Remitoro E7777 Adverse drug reactions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Remitoro

Participants with recurrent or refractory peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL) will be administered with Remitoro 9 microgram per kilogram (mcg/kg), intravenous (IV) infusion, over 1 hour once daily for 5 consecutive days followed by 16 days withdrawal period in a 21 day cycle (up to maximum of 8 cycles). The dosage will be adjusted depending on the condition of the participant. All the participants will be observed for up to 24 weeks prospectively.

Remitoro

Intervention Type DRUG

Intravenous infusion.

Interventions

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Remitoro

Intravenous infusion.

Intervention Type DRUG

Other Intervention Names

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Denileukin diftitox

Eligibility Criteria

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Inclusion Criteria

1\. Participants with PTCL or CTCL.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eisai Trial Site 3

Nagoya, , Japan

Site Status

Eisai Trial Site 1

Osaka, , Japan

Site Status

Eisai Trial Site 2

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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E7777-M081-501

Identifier Type: -

Identifier Source: org_study_id