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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mogamulizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mogamulizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From date of consent, at every treatment and follow up visit, up to 27 months |
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Inclusion Criteria:
Histologically confirmed diagnosis of MF or SS
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | United States | ||
| University of California Irvine |
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|
|
| Irvine |
| California |
| 92697 |
| United States |
| Stanford Cancer Center | Stanford | California | 94304 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| New York Presbyterian Hospital | New York | New York | 10032 | United States |
| University of Pittsburgh School of Medicine | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Hôpital Saint Louis | Paris | France |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino | Turin | Italy |
| Hospital del Mar | Barcelona | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain |
| Hospital Universitario De Salamanca | Salamanca | Spain |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital | London | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | United Kingdom |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C549035 | mogamulizumab |
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