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.
Recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Mogamulizumab | 0761, KW0761, Poteligeo | Mogamulizumab |
| Name | Type | Description | Interventions |
|---|---|---|---|
| Mogamulizumab | Experimental |
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Number, percentage and severity of treatment emergent adverse events |
| Time Frame: | From date of consent, at every treatment and follow up visit, up to 27 months |
| Safety Issue: | |
| Description: | Adverse events will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (v. 5.0). |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Kyowa Kirin, Inc. |
August 17, 2021
