Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease

Официальное название

Efficacy and Safety of the RD Regimen (Lenalidomide, Dexamethasone) in the Treatment of Rosai-Dorfman Disease: A Prospective, Multicenter, Single-Arm Study.

Обзор

In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.

Подробное описание

Patients received oral lenalidomide 25mg on days 1-21 and dexamethasone 40mg on days 1, 8, 15, 22, in 28-day cycles for 12 total cycles.

Вмешательства

• Препарат Lenalidomide
  The combination therapy period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. Combined with Dexamethasone: 40mg, orally, D1, 8, 15, 22, every 28 days per cycle. The single-agent maintenance period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. The total treatment duration is 24 cycles or until disease progression, death, or the occurrence of intolerable toxicity.
• Препарат Dexamethasone
  The combination therapy period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. Combined with Dexamethasone: 40mg, orally, D1, 8, 15, 22, every 28 days per cycle. The single-agent maintenance period consists of 12 cycles: Lenalidomide: 25mg, orally, D1-21, every 28 days per cycle. The total treatment duration is 24 cycles or until disease progression, death, or the occurrence of intolerable toxicity.

Первичные конечные точки

• Progression-free survival time （PFS) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (3)

• Overall Response Rate (ORR) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Overall Survival (OS) [Срок оценки: From enrollment to the end of treatment at 8 weeks"]
• Adverse events [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• Definitively diagnosed adult RDD patients;
• Aged between 18 and 80 years;
• Treatment-naive or refractory/relapsed;
• ECOG performance status score ≤ 2;
• Judged by clinicians as suitable for treatment with this protocol;
• Patients or their families able to understand the study protocol and willing to participate in the study, providing written informed consent.

Критерии исключения

• Subjects who have undergone major surgery within 4 weeks prior to the first dose of the study;
• Subjects who have received radiotherapy within 4 weeks prior to the first dose of the study;
• Subjects with a history of myocardial infarction within the past year;
• Patients with New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, or a history of NYHA Class 3 or 4 congestive heart failure;
• Pregnant or lactating women;
• Patients who cannot strictly practice contraception after participating in the study;
• Abnormal liver and kidney function: creatinine level ≥176.8 μmol/L (2 mg/dL), transaminase and bilirubin levels more than 2 times the upper limit of normal
• Abnormal blood counts: absolute neutrophil count less than 1×10\^9/L, platelet count less than 50×10\^9/L;
• Patients or their families who cannot understand the conditions and objectives of the study;
• Any other situation where the investigator considers the patient unsuitable to participate in this trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Department of Medical Oncology, National Cancer Center/National Clinical Research Center f — Пекин

Идентификаторы

NCT: NCT07187167 · NCCH005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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