RecruitingPhase 2NCT07187167

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

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

40 participants

Start Date

Apr 12, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria6

  • 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 Criteria10

  • 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.

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Interventions

DRUGLenalidomide

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.

DRUGDexamethasone

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.


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

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NCT07187167


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