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)

NCT04745234 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Kyowa Kirin, Inc.
Phase	Phase 2
Status	UNKNOWN
Enrolment	34
Start date	2021-08-16
Completion	2025-05

Conditions

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

Interventions

• Mogamulizumab

Primary outcomes

• 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).

Countries

United States, France, Italy, Spain, United Kingdom