Lenalidomide plus dexamethasone for Rosai‑Dorfman disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial testing an oral lenalidomide and intermittent dexamethasone regimen in adults with confirmed Rosai‑Dorfman disease. Participants receive lenalidomide 25 mg orally on days 1–21 and dexamethasone 40 mg on days 1, 8, 15, and 22 of each 28‑day cycle, for up to 12 cycles. The protocol enrolls treatment‑naive and relapsed/refractory patients with ECOG performance status ≤2 who are judged suitable by their clinicians. The study monitors treatment safety and disease response during and after the treatment period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where it's running

• Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
  Beijing, China Recruiting

Study contacts

• Study coordinator: Xinxin XX Cao, doctor
• Email: caoxinxin@126.com
• Phone: 18618315968

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.