Status:
RECRUITING
Efficacy and Safety of the RD Regimen(Lenalidomide, Dexamethasone) for Rosai-Dorfman Disease
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Rosai-Dorfman Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
In patients with Rosai-Dorfman disease (RDD), a treatment regimen of lenalidomide combined with dexamethasone is planned to be used.
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 12 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07187167
Start Date
April 12 2025
End Date
April 12 2027
Last Update
September 22 2025
Active Locations (1)
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1
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