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NCT Number: NCT07187167

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Location status: Recruiting

Location contact

Xinxin XX Cao

CONTACT

[email protected]

+86-18618315968

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: INNs

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.

Other names: INNs

Primary outcomes

  1. Progression-free survival time (PFS)

    Time frame: 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 outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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) .

  2. Overall Survival (OS)

    Time frame: From enrollment to the end of treatment at 8 weeks"

    OS was measured from RD start to death or last follow-up

  3. Adverse events

    Time frame: 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.

Other outcomes

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

    Time frame: From enrollment to the end of treatment at 8 weeks"

    Correlation between the positivity of NGS in MAPK pathway and therapeutic efficacy/PFS

  2. Fact-G

    Time frame: From enrollment to the end of treatment at 8 weeks

    The score of Functional Assessment of Cancer Therapy - General

Study contacts

Contact information is provided by the study sponsor or research team.

Huilei HL Miao, doctor

CONTACT

[email protected]

+86-18801317695

Xinxin XX Cao, doctor

CONTACT

[email protected]

18618315968

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 22, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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