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

NCT07187167 | Recruiting Phase 2

• 1 other identifier: NCCH005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rosai-Dorfman Disease

Outcome Measures

Primary Outcomes (1)

• Progression-free survival time （PFS)

  PFS defined as the time from RD initiation to first documented disease progression, relapse after RD, death from any cause, or last follow-up.

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (3)

• Overall Response Rate (ORR)

  From enrollment to the end of treatment at 8 weeks

• Overall Survival (OS)

  From enrollment to the end of treatment at 8 weeks"

• Adverse events

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (2)

• Correlation between next-generation sequence (NGS) and therapeutic efficacy/PFS

  From enrollment to the end of treatment at 8 weeks"

• Fact-G

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Patients with RDD

EXPERIMENTAL

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

Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Lenalidomide DRUG

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.

Also known as: INNs

Patients with RDD

Dexamethasone DRUG

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.

Also known as: INNs

Patients with RDD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (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

RECRUITING

MeSH Terms

Conditions

Histiocytosis, Sinus

Interventions

Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Histiocytosis, Non-Langerhans-Cell; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Xinxin XX Cao, doctor

  NCC, CICAMS

  STUDY CHAIR

Central Study Contacts

Xinxin XX Cao, doctor

CONTACT

18618315968; caoxinxin@126.com

Huilei HL Miao, doctor

CONTACT

+86-18801317695; miaohl13@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A multicenter, prospective, interventional study, with a planned number of subjects: approximately 40 cases.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 22, 2025
• Study Start: April 12, 2025
• Primary Completion (Estimated): April 12, 2027
• Study Completion (Estimated): April 12, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)