Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Phase 2

Active, not recruiting

• Conditions: Cutaneous T-Cell Lymphoma, Relapsed; Cutaneous T-Cell Lymphoma Refractory
• Interventions: Drug: Mogamulizumab

• Registration Number: NCT04745234
• Lead Sponsor: Kyowa Kirin, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-09
• Study Start: 2021-08-16
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mogamulizumab	Mogamulizumab	-

Primary Outcome Measures

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

Trial Locations

Locations (16)

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

University of California Irvine; 🇺🇸 Irvine, California, United States

Hospital del Mar; 🇪🇸 Barcelona, Spain

Stanford Cancer Center; 🇺🇸 Stanford, California, United States

Hôpital Saint Louis; 🇫🇷 Paris, France

Azienda Ospedaliera Città della Salute e della Scienza di Torino; 🇮🇹 Turin, Italy

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

Hospital Universitario De Salamanca; 🇪🇸 Salamanca, Spain

Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital; 🇬🇧 London, United Kingdom

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States