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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-01011 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 22233 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is being done to assess mogamulizumab-associated rash in patients diagnosed with mycosis fungoides or sezary syndrome and treated with standard of care mogamulizumab. One of the most common side effects of mogamulizumab is a rash, currently named mogamulizumab-associated rash (MAR) which can look like MF or SS. However, mogamulizumab-associated rash (MAR) does not indicate failure of mogamulizumab, and may be a sign that the drug is working. If not properly evaluated, mogamulizumab-associated rash (MAR) could be misinterpreted as worsening of mycosis fungoides/sezary syndrome, which could lead doctors to recommend stopping mogamulizumab treatment early. The information learned by doing this research study may help tell the difference between mogamulizumab-associated rash (MAR) (sometimes also called "drug eruption") and worsening of the disease. It may also help to uncover information about the cause of mogamulizumab-associated rash (MAR).
PRIMARY OBJECTIVE:
I. To assess the incidence of mogamulizumab-associated rash (MAR) and its association with overall response in patients with cutaneous T-cell lymphoma (CTCL); mycosis fungoides [MF] and sezary syndrome [SS] subtypes) treated with mogamulizumab.
OUTLINE: This is an observational study.
Patients complete questionnaires, have photographs of their skin taken, and undergo blood sample collection and skin biopsies on study. Patients' medical records are also reviewed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients complete questionnaires, have photographs of their skin taken, and undergo blood sample collection and skin biopsies on study. Patients' medical records are also reviewed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binary incidence of mogamulizumab-associated rash (MAR) | Will be estimated as a binomial proportion along with the 95% exact binomial confidence interval. | Up to 3 years |
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Inclusion Criteria:
* Adult patients (>= 18 years of age) diagnosed with relapsed/refractory Mycosis Fungoides (MF) stage IB, IIA, IIB, III and IV or Sezary Syndrome(SS), and selected by their treating physician to receive single agent mogamulizumab (newly initiated)
Exclusion Criteria:
* Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids
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Patients diagnosed with relapsed/refractory Mycosis Fungoides (MF) stage IB, IIA, IIB, III and IV or Sezary Syndrome(SS), and selected by their treating physician to receive single agent mogamulizumab (newly initiated).
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Querfeld | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| Stanford Cancer Institute Palo Alto | Not yet recruiting | Palo Alto | California | 94304 | United States |
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| Moffitt Cancer Center | Not yet recruiting | Tampa | Florida | 33612 | United States |
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| Emory University Hospital/Winship Cancer Institute | Not yet recruiting | Atlanta | Georgia | 30322 | United States |
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| Johns Hopkins University/Sidney Kimmel Cancer Center | Not yet recruiting | Baltimore | Maryland | 21287 | United States |
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| Brigham and Women's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| Siteman Cancer Center at Washington University | Recruiting | St Louis | Missouri | 63110 | United States |
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| Thomas Jefferson University Hospital | Not yet recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| M D Anderson Cancer Center | Not yet recruiting | Houston | Texas | 77030 | United States |
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| Fred Hutchinson Cancer Center | Not yet recruiting | Seattle | Washington | 98109 | United States |
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| ID | Term |
|---|---|
| D009182 | Mycosis Fungoides |
| D012751 | Sezary Syndrome |
| ID | Term |
|---|---|
| D016410 | Lymphoma, T-Cell, Cutaneous |
| 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 |
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