Mogamulizumab Q4week Dosing in Participants With R/R CTCL
Purpose
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.
Conditions
- Cutaneous T-Cell Lymphoma, Relapsed
- Cutaneous T-Cell Lymphoma Refractory
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Mogamulizumab |
|
Recruiting Locations
Tulane University School of Medicine
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
More Details
- Status
- Recruiting
- Sponsor
- Kyowa Kirin, Inc.