Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05137847
Other study ID # E7777-M081-501
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 24, 2021
Est. completion date March 17, 2023

Study information

Verified date December 2023
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date March 17, 2023
Est. primary completion date March 17, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Participants with PTCL or CTCL.

Study Design


Intervention

Drug:
Remitoro
Intravenous infusion.

Locations

Country Name City State
Japan Eisai Trial Site 3 Nagoya
Japan Eisai Trial Site 1 Osaka
Japan Eisai Trial Site 2 Tokyo

Sponsors (1)

Lead Sponsor Collaborator
Eisai Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Participants With Best Overall Response (BOR) Percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on physician assessment will be determined. PTCL is evaluated according to revised response criteria for malignant lymphoma (Cheson, 2007). CTCL is evaluated according to clinical endpoints and response criteria in mycosis fungoides and sezary syndrome (Olsen, 2011). CR: Disappearance of all evidence of disease; PR: Regression of measurable disease and no new sites. Up to Week 24
See also
  Status Clinical Trial Phase
Terminated NCT03357224 - PARCT: Trial of Atezolizumab in Relapsed/Refractory Cutaneous T Cell Lymphoma (CTCL) Phase 2
Completed NCT02567656 - Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma Phase 1
Completed NCT00051012 - Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients Phase 4
Recruiting NCT03646422 - AEDV Registry of Primary Cutaneous Lymphoma
Terminated NCT03789864 - Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides N/A
Active, not recruiting NCT04998331 - A Spanish Medical Record Review of Adults With Relapsed or Refractory CD30+ Malignancies When Re-treated With Brentuximab-vedotin
Active, not recruiting NCT02953301 - Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) Phase 2
Completed NCT01433731 - Safety, Pharmacodynamics (PD), Pharmacokinetics (PK) Study of SHP141 in 1A, 1B, or 2A Cutaneous T-Cell Lymphoma (CTCL) Phase 1
Completed NCT01486277 - A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma Phase 2
Active, not recruiting NCT03902184 - IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma Phase 2
Completed NCT00896493 - Ph II of Non-myeloablative Allogeneic Transplantation Using TLI & ATG In Patients w/ Cutaneous T Cell Lymphoma Phase 2
Completed NCT00211198 - Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL) Phase 4
Terminated NCT03601819 - Pacritinib in Relapsed/Refractory Lymphoproliferative Disorders Phase 1
Withdrawn NCT03742804 - Study Of Intratumoral G100 In Cutaneous T Cell Lymphoma Phase 2
Completed NCT02836886 - VircapSeq Virus Detection in Sézary Syndrome
Completed NCT00050999 - Study of ONTAK (Denileukin Diftitox) in Cutaneous T-Cell Lymphoma (CTCL) Patients Phase 4
Terminated NCT02323659 - Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas Phase 4
Recruiting NCT02840747 - Tissue Repository: CTCL Collection Protocol
Completed NCT03192202 - AFM13 in Relapsed/Refractory Cutaneous Lymphomas Phase 1/Phase 2
Terminated NCT02811783 - Naloxone Hydrochloride Study for Relief of Pruritus in Patients With MF or SS Forms of CTCL Phase 3