Mogamulizumab Q4week Dosing in Participants With R/R CTCL
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.
- Cutaneous T-Cell Lymphoma, Relapsed
- Cutaneous T-Cell Lymphoma Refractory
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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.
- Current evidence of large cell transformation; - Prior treatment with mogamulizumab; - History of allogeneic transplant.
- Phase 2
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
- Kyowa Kirin, Inc.
Study ContactKyowa Kirin, Inc.