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

Not Applicable

Recruiting

• Conditions: Rosai-Dorfman Disease
• Interventions: Drug: Lenalidomide; Drug: Dexamethasone

• Registration Number: NCT07187167
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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.

Study Timeline

• Study Start: 2025-04-12
• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-22
• Last Update Posted: 2025-09-22
• Primary Completion: 2027-04-12
• Study Completion: 2027-04-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with RDD	Lenalidomide	Patients with RDD who are treatment-naive or have not previously received lenalidomide; aged 18-80 years; ECOG PS 0-2.
Patients with RDD	Dexamethasone	Patients with RDD who are treatment-naive or have not previously received lenalidomide; aged 18-80 years; ECOG PS 0-2.

Primary Outcome Measures

Name	Time	Method
Progression-free survival time （PFS)	From enrollment to the end of treatment at 8 weeks	PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up.

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	From enrollment to the end of treatment at 8 weeks	The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) .
Overall Survival (OS)	From enrollment to the end of treatment at 8 weeks"	OS was measured from RD start to death or last follow-up
Adverse events	From enrollment to the end of treatment at 8 weeks	Toxicities were recorded and graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Trial Locations

Locations (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