A Phase 2 interventional study of Mogamulizumab in Cutaneous T-Cell Lymphoma, Relapsed and Cutaneous T-Cell Lymphoma Refractory, sponsored by Kyowa Kirin, Inc.. Active, not recruiting at 16 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-25.
Sponsored by Kyowa Kirin, Inc. · Phase 2, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 34 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Kyowa Kirin, Inc. is the lead sponsor of 34 studies on the registry; 2 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Histologically confirmed diagnosis of MF or SS
Exclusion Criteria:
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.
Also known as: 0761, KW0761, Poteligeo
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).
Time frame: From date of consent, at every treatment and follow up visit, up to 27 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Kyowa Kirin, Inc.