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

NCT05137847 | Completed

• 1 other identifier: E7777-M081-501
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with ADR

  Incidence of ADR, especially for capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders will be assessed. An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled.

  Up to Week 24

Secondary Outcomes (1)

• Percentage of Participants With Best Overall Response (BOR)

  Up to Week 24

Study Arms (1)

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.

Drug: Remitoro

Interventions

Remitoro DRUG

Intravenous infusion.

Also known as: Denileukin diftitox

Remitoro

Eligibility Criteria

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

Study Population

Participants with recurrent or refractory PTCL or CTCL administered Remitoro will be included in this study.

You may qualify if:

• \. Participants with PTCL or CTCL.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (3)

Eisai Trial Site 3

Nagoya, Japan

Location

Eisai Trial Site 1

Osaka, Japan

Location

Eisai Trial Site 2

Tokyo, Japan

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Drug-Related Side Effects and Adverse Reactions

Interventions

denileukin diftitox

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; Chemically-Induced Disorders

Study Design

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

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: November 30, 2021
• Study Start: May 24, 2021
• Primary Completion: March 17, 2023
• Study Completion: March 17, 2023
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

JP (3)