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Идёт набор NCT07003100

A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab

— Наблюдательное Recurrent Mycosis Fungoides Recurrent Sezary Syndrome Refractory Mycosis Fungoides Refractory Sezary Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Non-Interventional Study.
Кому может быть актуально
Состояния в реестре: Recurrent Mycosis Fungoides, Recurrent Sezary Syndrome, Refractory Mycosis Fungoides, Refractory Sezary Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Prospective, US-Based Study Assessing Mogamulizumab-Associated Rash in Patients Diagnosed With Mycosis Fungoides or Sézary Syndrome and Treated With Standard of Care Mogamulizumab

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое Non-Interventional Study
    Non-interventional study

Первичные конечные точки

  • Binary incidence of mogamulizumab-associated rash (MAR) [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • \* 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)
  • Signed informed consent
  • Willing to undergo baseline biopsy and during treatment to evaluate for Mogamulizumab-Associated Rash (MAR) if clinically indicated
  • Willing to provide blood sample at baseline, and if applicable, at onset of Mogamulizumab-Associated Rash (MAR)

Критерии исключения

  • \* Other concomitant systemic and skin directed Cutaneous T-cell Lymphoma (CTCL) regimens except for topical steroids
  • Prior treatment with mogamulizumab

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 10 центров
  • City of Hope Medical Center — Duarte
  • Stanford Cancer Institute Palo Alto — Palo Alto
  • Moffitt Cancer Center — Tampa
  • Emory University Hospital/Winship Cancer Institute — Atlanta
  • Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore
  • Brigham and Women's Hospital — Boston
  • Siteman Cancer Center at Washington University — St Louis
  • Thomas Jefferson University Hospital — Philadelphia
  • … и ещё 2 центра

Идентификаторы

NCT: NCT07003100 · 22233 · NCI-2024-01011 · 22233 · P30CA033572

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗