Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Cutaneous T-Cell Lymphoma Refractory Clinical Trial

Official title:

Open-Label, Phase 2 Study to Assess the Safety of Mogamulizumab Given Every 4 Weeks Following Induction in Participants With Relapsed/Refractory Cutaneous T-Cell Lymphoma (CTCL)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04745234
• Other study ID #: 0761-016
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 16, 2021
• Est. completion date: May 2025

Study information

• Verified date: April 2024
• Source: Kyowa Kirin Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, multicenter, Phase 2 study to evaluate the safety and tolerability of mogamulizumab given Q4W following initial weekly induction in adult participants with relapsed/refractory MF and SS subtypes of CTCL. The study is composed of a 28-day Screening Period during which participants are screened for entry into this study, followed by a treatment period of up to 2 years from Cycle 1 Day 1.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed diagnosis of MF or SS
• Stage IB, II-A, II-B, III, or IV;
• Participants who have failed at least one prior course of systemic therapy (e.g., interferon, bexarotene, photopheresis, anti-neoplastic chemotherapy). Psoralen plus ultraviolet light therapy (PUVA) is not considered a systemic therapy.

Exclusion Criteria:

• Current evidence of large cell transformation;
• Prior treatment with mogamulizumab;
• History of allogeneic transplant.

Related Conditions & MeSH terms

• Cutaneous T-Cell Lymphoma Refractory
• Cutaneous T-Cell Lymphoma, Relapsed
• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoma, T-Cell, Peripheral

Intervention

Drug:
• Mogamulizumab
For the first 28-day induction cycle (C1), mogamulizumab 1 mg/kg will be administered as an IV infusion through a 0.22- or 0.2-µm in-line filter over at least 60 minutes on Days 1, 8, 15, and 22. For all subsequent 28-day cycles (C2, 3, 4, etc.), mogamulizumab 2 mg/kg will be administered as an IV infusion over at least 60 minutes on Day 1 of each subsequent therapy cycle.

Locations

Country	Name	City	State
France	Hôpital Saint Louis	Paris
Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Turin
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario De Salamanca	Salamanca
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United States	City of Hope National Medical Center	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of California Irvine	Irvine	California
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	New York Presbyterian Hospital	New York	New York
United States	University of Pittsburgh School of Medicine	Pittsburgh	Pennsylvania
United States	Stanford Cancer Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Kirin, Inc.

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number, percentage and severity of treatment emergent adverse events	Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0).	From date of consent, at every treatment and follow up visit, up to 27 months